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Name:Bite Beauty Spf 15 Sheer Balm
Manufacturer:Susanne Lang Fragrance Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Bite Beauty SPF 15 Sheer Balm

BITE BEAUTY SPF 15 SHEER BALM - octinoxate and oxybenzone ointment 
Susanne Lang Fragrance Inc.

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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Bite Beauty SPF 15 Sheer Balm

Active Ingredients

Octinoxate (Sunscreen) 7.50%,

Oxybenzone (Sunscreen) 3.00%

Other Ingredients

Organic Ricinus Communis (Castor) Seed Oil, Organic Simmondsia Chinensis (JoJoba) Seed Oil, Organic Cera Alba (Beeswax), Organic Argania Spinosa (Argan) Kernel Oil, Euphorbia Cerifera Candelilla) Wax, Butryospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Organic Copernicia Cerifera (Carnauba) Wax, Silica, Lauryl Lysine, Natural Flavor, Tocopheral (Vitamin E), Ascorbic Acid (Vitamin C), Trans-resveratrol, Phenoxyethanol (Coconut Derived), Siraitia Grosvenorii (Monk Fruit Concentrate)

May Contain

Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Carmine (CI 75470), FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), FD&C Yellow No. 6 (CI 15985), FD&C Red No. 40 (CI 16035), Manganese Violet (CI 77742)

Package/Label Principal Display Panel - Creme SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Creme SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Violet SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Violet SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Carmine SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Carmine SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Claret SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Claret SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Burgundy SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Burgundy SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Concord SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Concord SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Starfruit SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Starfruit SPF 15 Sheer Balm Carton Label

Package/Label Principal Display Panel - Sparkling SPF 15 Sheer Balm

Bite

Beauty

Natural

Food Grade

SPF 15

Sheer Balm

with Resveratrol

Net Wt.

.10 oz

5 mg of

Resveratrol

Deliver the

Anti-Oxidant

Equivalent of

5 Glasses of

Red Wine

Carton Label

Sparkling SPF 15 Sheer Balm Carton Label


BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1401
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1401-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1402
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1402-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1403
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1403-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1404
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1404-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1405
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1405-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1406
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1406-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1407
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1407-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

BITE BEAUTY SPF 15 SHEER BALM 
octinoxate oxybenzone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47202-1408
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED  
JOJOBA OIL  
YELLOW WAX  
ARGAN OIL  
CANDELILLA WAX  
SHEA BUTTER  
CARNAUBA WAX  
SILICON DIOXIDE  
LAUROYL LYSINE  
ALPHA-TOCOPHEROL  
ASCORBIC ACID  
RESVERATROL  
PHENOXYETHANOL  
MICA  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
INDIGOTINDISULFONATE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47202-1408-1 2.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/31/2011

Labeler - Susanne Lang Fragrance Inc. (209553648)

Revised: 02/2011 Susanne Lang Fragrance Inc.



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


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