CETAPHIL - octocrylene and avobenzone lotion 
Galderma Laboratories, L.P.

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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Cetaphil® Daily Facial Moisturizer

Active Ingredients

Avobenzone 3%
Octocrylene 10%

Purpose

Avobenzone..........Sunscreen
Octocrylene..........Sunscreen

Use(s)

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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
SUN PROTECTION MEASURES: Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially 10am – 2 pm.
• Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENTS:

Water, Diisopropyl Adipate, Cyclomethicone, Glycerin, Glyceryl Steartae, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer 940, Disodium EDTA, Triethanolamine.

Other Information

• Protect this product from excessive heat and direct sun.
• May stain some fabrics.

Questions?

1-866-735-4137

PRINCIPAL DISPLAY PANEL

p50935-3-4oz-spf15-carton-v2

Cetaphil®

Every Age. Every Stage. Every Day.®

Daily Facial
Moisturizer

with sunscreen

BROAD SPECTRUM SPF 15

FOR ALL SKIN TYPES

Non-comedogenic
Lightweight, non-greasy
Fragance free

UVA/UVB Protection

4 FL OZ (118 mL)

GALDERMA

This light, non-greasy moisturizer nourishes and hydrates your skin while also protecting it from the sun's harmful rays.

Restores and improves your skin's ability to retain vital moisture.

Non-comedogenic
PABA free / Fragrance free

Dermatologist recommended

DIRECTIONS: Apply daily to face and neck, away from eyes. Reapply as necessary throughout the day and before sun exposure.

Importance of daily sunscreen protection:

UV rays from the sun are made of UVA and UVB. It is important to protect against both UVA and UVB to prevent sunburn and other skin damage.

Use in conbination with a complete regimen of Cetaphil® Cleansers and Moisturizers for you daily skin care needs.

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA
GALDERMA is a registered trademark
Made in Canada
cetaphil.com
P50935-3

10142-1014-cetaphil-men-dfl-crtn

Cetaphil® MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM SPF 15

Moisturizes and protects skin without clogging pores

Dermatologist developed and tested

4 FL OZ (118 mL)

GALDERMA

Cetaphil® MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM SPF 15

Your face lotion should protect your skin from harsh outdoor elements and the effects of your razor.

This lightweight formula absorbs quickly and locks in moisture to strengthen skin's natural moisture barrier. Perfect for post-shave, it soothes sensitive skin and helps defend skin from the sun's harmful rays to help prevent early signs of aging.

The result is healthy, hydrated skin all day long...or all night long.

Non-irritating. Won't clog pores. Unscented, Dermatologist developed and tested.

Cetaphil® MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM SPF 15

DIRECTIONS: Apply daily to face and neck, away from eyes. Reapply as necessary throughout the day and before sun exposure.

Importance of daily sunscreen protection:

UV rays from the sun are made of UVA and UVB. It is important to protect against both UVA and UVB to help prevent sunburn and other skin damage.

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

Distributed by:

Galderma Laboratories L.P.

Fort Worth, TX 76177 USA

GALDERMA is a registered trademark

Made in Canada

cetaphil.com

10142-1014

CETAPHIL  
octocrylene, avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-3928
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10 g  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
Cyclomethicone (UNII: NMQ347994Z)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Polyoxyl 100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Carbomer Copolymer Type A (UNII: 71DD5V995L)  
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
Edetate Disodium (UNII: 7FLD91C86K)  
Trolamine (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0299-3928-04 1 in 1 CARTON
1 118 mL in 1 TUBE
2 NDC:0299-3928-07 1 in 1 CARTON
2 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/01/2000
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Business Operations
G Production Inc. 251676961 MANUFACTURE(0299-3928)

Revised: 5/2011
Document Id: dbbac4e1-5dbf-4f87-b5b7-68238df9a33e
Set id: 2a6bc3f2-4e52-252b-d051-94be1ee0cc00
Version: 3
Effective Time: 20110509
 
Galderma Laboratories, L.P.