BOTANICS FACE RENEWAL SUNSCREEN SPF 15- octinoxate and avobenzone cream

BOTANICS FACE RENEWAL SUNSCREEN SPF 15 by

Drug Labeling and Warnings

BOTANICS FACE RENEWAL SUNSCREEN SPF 15 by is a Otc medication manufactured, distributed, or labeled by BCM Ltd, The Boots Company PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15

Active Ingredients                  Purpose

Avobenzone 3.0%               Sunscreens

Octinoxate 6.0%

PURPOSE

Uses

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

WARNINGS AND PRECAUTIONS

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.

HOW SUPPLIED

Colour may vary due to natural extracts

ASK DOCTOR

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help.

INDICATIONS & USAGE

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.

STORAGE AND HANDLING

Other Information

Do not store above 300C or 860F

INACTIVE INGREDIENT

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

Questions? 1-866-75-BOOTS

DESCRIPTION

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.

INFORMATION FOR PATIENTS

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

PRINCIPAL DISPLAY PANEL

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.jpg

PRINCIPAL DISPLAY PANEL

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.jpg

PRINCIPAL DISPLAY PANEL

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.jpg

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.0 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-057-01	1 in 1 CARTON
1		50 mL in 1 JAR

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	Business Operations
BCM Ltd		230780322	manufacture, analysis