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Name:Amorepacific Time Response No. 102
Manufacturer:Amorepacific
Category:Over-the-counter (OTC) Marketed Drugs


AMOREPACIFIC Time Response Skin Renewal Foundation SPF 18

AMOREPACIFIC  TIME RESPONSE NO. 102 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC  TIME RESPONSE NO. 104 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC  TIME RESPONSE NO. 106 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC  TIME RESPONSE NO. 202 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC  TIME RESPONSE NO. 204 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC  TIME RESPONSE NO. 206 - octinoxate, titanium dioxide and zinc oxide lotion 
AMOREPACIFIC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AMOREPACIFIC
Time Response
Skin Renewal Foundation
SPF 18

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 5%, TITANIUM DIOXIDE 4.15%, ZINC OXIDE 0.98%

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

For external use only.

When using this product

-Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

-Rash or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply smoothly before sun exposure and as needed.

Children under 6 months of age : ask a doctor

INACTIVE INGREDIENTS

CAMELLIA SINENSIS LEAF WATER, CYCLOPENTASILOXANE, TRIETHYLHEXANOIN, GLYCERIN, PHENYL TRIMETHICONE, CYCLOHEXASILOXANE, DIMETHICONE, PHYLLOSTACHIS BAMBUSOIDES JUICE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE, PANAX GINSENG ROOT EXTRACT, BUTYLENE GLYCOL, ALCOHOL, POLYMETHYL METHACRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BIS-ISOBUTYL PEG/PPG-10/7/DIMETHICONE COPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, OZOKERITE, ALUMINUM HYDROXIDE, SORBITAN ISOSTEARATE, PHENOXYETHANOL, STEARIC ACID, FRAGRANCE, SODIUM CITRATE, TRIETHOXYCAPRYLYLSILANE, SILICA, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, CAMELLIA JAPONICA SEED OIL, WATER, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, CAMELLIA SINENSIS LEAF EXTRACT, PUNICA GRANATUM EXTRACT, TRICHOLOMA MATSUTAKE EXTRACT, POLOXAMER 235, CAFFEINE, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, ETHOXYDIGLYCOL, EPIGALLOCATECHIN GALLATE, ZINC GLUCONATE, MAGNESIUM ASPARTATE, TOCOPHERSOLAN, POLOXAMER 338, HYDROLYZED GINSENG SAPONINS, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS FLOWER EXTRACT, COPPER GLUCONATE, CALCIUM GLUCONATE, GLYCINE SOJA (SOYBEAN) GERM EXTRACT, TREHALOSE, TITANIUM DIOXIDE, IRON OXIDES (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (102)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (102)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (104)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (104)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (106)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (106)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (202)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (202)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (204)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (204)

PRINCIPAL DISPLAY PANEL - 30 ml Carton (206)

AMOREPACIFIC

TIME RESPONSE
Skin Renewal Foundation
SPF 18

Principal Display Panel - 30 ml Carton (206)

AMOREPACIFIC   TIME RESPONSE NO. 102
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-505
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-505-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-505-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

AMOREPACIFIC   TIME RESPONSE NO. 104
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-506
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-506-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-506-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

AMOREPACIFIC   TIME RESPONSE NO. 106
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-507
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-507-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-507-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

AMOREPACIFIC   TIME RESPONSE NO. 202
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-508
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-508-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-508-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

AMOREPACIFIC   TIME RESPONSE NO. 204
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-509
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-509-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-509-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

AMOREPACIFIC   TIME RESPONSE NO. 206
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-510
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.5 mL  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 mL  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.294 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
TRIETHYLHEXANOIN  
GLYCERIN  
PHENYL TRIMETHICONE  
CYCLOMETHICONE 6  
DIMETHICONE  
PHYLLOSTACHYS RETICULATA RESIN  
ASIAN GINSENG  
BUTYLENE GLYCOL  
ALCOHOL  
SODIUM CHLORIDE  
FERRIC OXIDE YELLOW  
ALUMINUM HYDROXIDE  
PHENOXYETHANOL  
STEARIC ACID  
FERRIC OXIDE RED  
SODIUM CITRATE  
TRIETHOXYCAPRYLYLSILANE  
SILICON DIOXIDE  
FERROSOFERRIC OXIDE  
ETHYLHEXYLGLYCERIN  
EDETATE DISODIUM  
CAMELLIA JAPONICA SEED OIL  
WATER  
GINGER  
SUNFLOWER OIL  
GREEN TEA LEAF  
POMEGRANATE  
CAFFEINE  
DIETHYLENE GLYCOL MONOETHYL ETHER  
ZINC GLUCONATE  
MAGNESIUM ASPARTATE  
TOCOPHERSOLAN  
POLOXAMER 338  
GLYCYRRHIZA GLABRA  
CAMELLIA SINENSIS FLOWER  
COPPER GLUCONATE  
CALCIUM GLUCONATE  
TREHALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-510-02 30 mL in 1 BOTTLE, PUMP None
2 NDC:43419-510-11 1 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

Labeler - AMOREPACIFIC (687995683)
Establishment
Name Address ID/FEI Operations
AMOREPACIFIC 687995683 MANUFACTURE

Revised: 06/2011 AMOREPACIFIC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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