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Name:Botanics Face Renewal Sunscreen Spf 15
Manufacturer:Bcm Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Carton and jar labelling

BOTANICS FACE RENEWAL SUNSCREEN SPF 15  - octinoxate and avobenzone cream 
BCM Ltd

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 FACE RENEWAL CREAM SUNSCREEN SPF 15

Active Ingredients                  Purpose

Avobenzone 3.0%               Sunscreens

Octinoxate 6.0%

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.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

Colour may vary due to natural extracts

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

  • Massage onto face and neck with gentle upward strokes.
  • Apply evenly at least 15 minutes before sun exposure.
  • Reapply as required.
  • Not intended for children under the age of 12.

Other Information

Do not store above 300C or 860F

Inactive Ingredients

Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Glyceryl stearate, PEG-100 stearate, Dimethicone, Cetyl alcohol, Isopropyl myristate, Paraffin, Petrolatum, C18-36 acid glycol ester, Glycerin, Propylene glycol, Punica granatum extract, Phenoxyethanol, Vaccinium myrtillus extract, Mica, Hydroxyethylcellulose, Saccharum officinarum (Sugar cane) extract, Parfum (Fragrance), Xanthan gum, Sodium stearoyl lactylate, Sodium benzoate, Methylparaben, Citrus medica limonum (Lemon) peel extract, Citrus aurantium dulcis (Orange) flower extract, Hibiscus sabdariffa flower extract, Sorbitol, BHT, Tetrasodium EDTA, Butylparaben, Ethylparaben, Acer saccharum (Sugar maple) extract, Dipropylene glycol, Propylparaben, Isobutylparaben, CI 77891 (Titanium dixoide)

Questions? 1-866-75-BOOTS

Plant extracts at levels that really work.  Naturally.

This UVA/UVB balanced SPF 15 moisture cream helps diminish the visible signs of skin ageing by replenishing lost moisture and protecting against environmental damage.  With Hibiscus and Pomegranate extracts to promote skin renewal whilst smoothing away fine lines and wrinkles.

Dermatologically tested.

Mfd in the U.K. for BBI NG2 3AA. UK.

Dist in the USA by Boots Retail USA Inc.

Stamford CT 06901

www.boots.com

Carton label

FIRST SIGNS OF AGEING

Face Renewal Cream Sunscreen SPF 15

Hibiscus brightens

Pomegranate protects

PREMIERS SIGNES DU VIEILLISSEMENT

Crème Régénérante Visage Protection Solaire FPS 15

L'Hibiscus éclaircit

La Grenade protège

Boots

The Power of Plants

BOTANICS

50ml e 1.69 US Fl. Oz

../images_otc/botanics_fac_Face Renewal Cream carton.jpgFace Renewal Cream carton

Jar front label

Face Renewal Cream Sunscreen SPF 15

Crème Régénérante Visage Protection Solaire FPS 15

Boots

The Power of Plants

BOTANICS

50ml e 1.69 US Fl. Oz

../images_otc/botanics_fac_Face Renewal Cream front label.jpgFace Renewal Cream front label

Jar back label

ACTIVE INGREDIENTS/ACTIFS: Octinoxate 6.0%  Avobenzone 3.0%

WARNINGS: Colour may vary due to natural extracts.

Sun Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and sunburn.  After use of this product is stopped, use a sunscreen and limit sun exposure for at least a week.

MISE EN GARDE: La couleur peut varier en raison des extraits naturels.

Alert Solaire: Ce produit contient un alphahydroxyacide (AHA) qui peut accroître la sensibilité de votre peau et peut provoquer des coupe de soleil. Après avoir cessé d'utiliser ce produit, utilisez un écran solaire et attendez une semaine avant de vous exposure de nouveau.

Mdf in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK.

Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901

USA/Canada: Questions? 1-866-75-BOOTS

www.boots.com

../images_otc/botanics_fac_Face Renewal Cream back label.jpgFace Renewal Cream back label


BOTANICS FACE RENEWAL SUNSCREEN SPF 15 
octinoxate and avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-057
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.0 mL  in 50 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 mL  in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
BUTYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
DIMETHICONE  
CETYL ALCOHOL  
ISOPROPYL MYRISTATE  
PARAFFIN  
PETROLATUM  
GLYCERIN  
PROPYLENE GLYCOL  
POMEGRANATE  
PHENOXYETHANOL  
BILBERRY  
SUGARCANE  
XANTHAN GUM  
SODIUM BENZOATE  
METHYLPARABEN  
LEMON JUICE  
ORANGE  
SORBITOL  
BUTYLATED HYDROXYANISOLE  
BUTYLPARABEN  
ETHYLPARABEN  
MAPLE SYRUP  
PROPYLPARABEN  
ISOBUTYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11489-057-01 1 JAR ( JAR) in 1 CARTON contains a JAR
1 50 mL in 1 JAR This package is contained within the CARTON (11489-057-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/03/2010

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

Revised: 12/2010 BCM Ltd



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


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