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Name:Botanics Day Moisture Sunscreen Spf 12
Manufacturer:Boots Retail Usa Inc
Category:Over-the-counter (OTC) Marketed Drugs


carton and jar labelling

BOTANICS DAY MOISTURE SUNSCREEN SPF 12  - octinoxate, avobenzone and octisalate cream 
Boots Retail USA 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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carton and jar labelling

BOTANICS DAY MOISTURE CREAM SUNSCREEN SPF 12

Active Ingredients      Purpose

Avobenzone 3%            Sunscreens
Octinoxate 7.5%
Octisalate 2.5%

Uses

  • Provides moderate protection against the adverse effects of the sun.
  • Higher SPF gives more protection.

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.

Directions

  • Gently massage onto face and neck.
  • Apply evenly at least 15 minutes before sun exposure.
  • Reapply as required.
  • Not intended for children under the age of 12.
  • Not intended for protection while sunbathing.

Other information

Do not store above 30oC or 86oF

Inactive ingredients

Aqua (Water), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Apha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

USA Questions?1-866-75-BOOTS

Plant extracts at levels that really work.

This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target skin ageing.

Dermatologically tested


Mfd in the UK for Boots Beauty International Limited

NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc.

Stamford CT 06901

USA: Questions? 1-866-75-BOOTS

www.boots.com

ACTIVE INGREDIENTS: Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.5%.


IN-ACTIVE INGREDIENTS: Aqua (Water), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Alpha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

Mfd in the UK for BBI Ltd NG2 3AA. UK Dist in the USA

by Boots Retail USA Inc. Stamford CT 06901

USA: Questions? 1-866-75-BOOTS www.boots.com

Plant extracts at levels that really work.

This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target premature skin ageing.

Dermatologically tested.

Directions: Use daily, alone or under make up, following your cleansing routine. Massage onto skin using upward strokes.

Colour may vary due to natural extracts.

Warnings: Avoid contact with eyes. May cause irritation.

If contact occurs, rinse immediately with cold water.

If irritation persists, consult your physician immediately.

Avoid direct contact with fabric.

The Power of Plants

BOTANICS

DAY MOISTURE CREAM

Sunscreen SPF 12

With hydrating rice extract and honey to

restore, plump and smooth your skin.

50ml e 1.69 US Fl. Oz.Day Moisture Cream carton

The Power of Plants

BOTANICS

DAY MOISTURE CREAM

Sunscreen SPF 12

With hydrating rice extract and honey.

50ml e 1.69 US Fl. Oz.Day Moisture Cream label

Colour may vary due to natural extracts.


BOTANICS DAY MOISTURE SUNSCREEN SPF 12 
octinoxate, avobenzone and octisalate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68472-074
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.75 mL  in 50 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 mL  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE 1.25 mL  in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
BUTYLENE GLYCOL  
MEDIUM-CHAIN TRIGLYCERIDES  
DIMETHICONE  
HONEY  
CETYL ALCOHOL  
PHENOXYETHANOL  
C13-14 ISOPARAFFIN  
RICE BRAN  
METHYLPARABEN  
SODIUM BENZOATE  
PROPYLPARABEN  
CITRIC ACID MONOHYDRATE  
SODIUM CHLORIDE  
EDETATE SODIUM  
BUTYLATED HYDROXYTOLUENE  
ETHYLPARABEN  
BUTYLPARABEN  
ISOBUTYLPARABEN  
FD&C YELLOW NO. 5  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68472-074-01 1 JAR ( JAR) in 1 CARTON contains a JAR
1 50 mL in 1 JAR This package is contained within the CARTON (68472-074-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/25/2010

Labeler - Boots Retail USA Inc (143151533)
Registrant - The Boots Company PLC (218622660)
Establishment
Name Address ID/FEI Operations
BCM Ltd 230780322 manufacture, analysis

Revised: 08/2010 Boots Retail USA Inc



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


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