BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15 - octinoxate and avobenzone 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

Active Ingredients                  Purpose

Avobenzone 3.0%               Sunscreens

Octinoxate 6.0%

Uses

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

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

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

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

Face Renewal Cream back label.jpgFace Renewal Cream back label

BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15 
octinoxate and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.0 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POMEGRANATE (UNII: 56687D1Z4D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BILBERRY (UNII: 9P2U39H18W)  
SUGARCANE (UNII: 81H2R5AOH3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LEMON JUICE (UNII: AGN709ANTJ)  
ORANGE (UNII: 5EVU04N5QU)  
SORBITOL (UNII: 506T60A25R)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
MAPLE SYRUP (UNII: 75UOH57984)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68472-056-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/03/2010
Labeler - Boots Retail USA Inc (143151533)
Registrant - The Boots Company PLC (218622660)
Establishment
NameAddressID/FEIBusiness Operations
BCM Ltd230780322manufacture, analysis

Revised: 2/2010
Document Id: baf9148b-fb54-48ef-a82f-f0a3d66b4822
Set id: b49d5c35-54b3-4a6b-8d07-ee1fb0805103
Version: 3
Effective Time: 20100224
 
Boots Retail USA Inc