CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion

Cetaphil Daily Facial Moisturizer with suncreen SPF 50 by

Drug Labeling and Warnings

Cetaphil Daily Facial Moisturizer with suncreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., G Production Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients.....Purpose

Octinoxate 7.5% .................Sunscreen
Octisalate 5% .....................Sunscreen
Octocrylene 7% ..................Sunscreen
Oxybenzone 6% .................Sunscreen
Titanium Dioxide 5.7% ........Sunscreen

Uses

Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.  Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer, Cyclomethicone, Stearic Acid, Dimethiconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Triethanolamine, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Carbomer, Methylparaben, Xanthan Gum

Other Information

Protect this product from excessive heat and direct sun.

Questions?

1-866-735-4137

Package Labels

Cetaphil®

Daily Facial

Moisturizer

with sunscreen

SPF 50+

Face All skin types

Non-comedogenic

Non-irritating

Fragrance free

1.7 FL OZ (50 mL)

Cetaphil

Daily Facial

Moisturizer

with sunscreen

SPF 50+

For all skin types

This clinically proven facial moisturizer nourishes and hydrates your skin while helping to defend against sunburn.

All day moisturizer leaves skin feeling soft and smooth

Non-comedogenic

Non-irritating

Fragrance free

Actual Size

Cetaphil

Daily Facial

Moisturizer

with sunscreen

SPF 50+

For all skin types

Use in combination with a complete regimen of Cetaphil cleansers and moisturizers for your daily skin care needs.

To find out more about Cetaphil products, visit cetaphil.com

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

CETAPHIL is a registered trademark.

Made in Canada

cetaphil.com

P51425-5

INGREDIENTS AND APPEARANCE

CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 
octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4930
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
CYCLOMETHICONE (UNII: NMQ347994Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4930-02	1 in 1 CARTON	01/01/2012
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2012

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4930)