Your browser does not support JavaScript! CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]
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CETAPHIL (octocrylene, avobenzone) lotion
[Galderma Laboratories, L.P.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients

Avobenzone 3%
Octocrylene 10%

Purpose

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

Use(s)

Filters out the sun's harmful rays to help prevent:

  • skin damage
  • freckling
  • uneven coloration

Warnings

For external use only, not to be swallowed

When using this product

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • signs of irritation or rash appear and persist.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply daily to face and neck, away from eyes.

Other Information

  • Moderate Sun Protection Product.
  • SUN ALERT: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • May stain some fabrics.

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

Carton

Cetaphil®

Every Age. Every Stage. Every Day.®

Daily Facial
Moisturizer

SPF15

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.

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.

Marketed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA
GALDERMA is a registered trademark
Made in Canada
cetaphil.com
P50935-2

Sample

Cetaphil®

Daily Facial
Moisturizer

SPF15

UVA/UVB Protection
Non-comedogenic

.25 FL OZ (7 mL)

USE: Sunscreen

ACTIVE INGREDIENTS:
AVOBENZONE 3%,
OCTOCRYLENE 10%

DIRECTIONS: Apply daily to face and neck, away from eyes.

Marketed by:
Galderma® Laboratories, L.P.
Fort Worth, Texas 76177 USA
Made in Canada
cetaphil.com
SAMPLE, NOT FOR SALE

P50928-2

CETAPHIL  
octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0299-3928
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (Octocrylene) Octocrylene10 g  in 100 mL
Avobenzone (Avobenzone) Avobenzone3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Diisopropyl Adipate 
Cyclomethicone 
Glycerin 
Glyceryl Monostearate 
Polyoxyl 100 Stearate 
Phenoxyethanol 
Benzyl Alcohol 
Carbomer Copolymer Type A 
Carbomer Homopolymer Type C 
Edetate Disodium 
Trolamine 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0299-3928-041 in 1 CARTON
1118 mL in 1 TUBE
2NDC:0299-3928-024 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2000
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961MANUFACTURE(0299-3928)

Revised: 1/2013
 
Galderma Laboratories, L.P.

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