CETAPHIL OIL ABSORBING SPF 30- avobenzone, octisalate, octocrylene lotion

Cetaphil Oil Absorbing SPF 30 by

Drug Labeling and Warnings

Cetaphil Oil Absorbing SPF 30 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

AVOBENZONE 3%
OCTISALATE 5%
OCTOCRYLENE 7%

Purpose

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 - 2pm.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Carbomer, Ceramide NP, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Hydroxide, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Water, Xanthan Gum, Zinc Gluconate

Other Information

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

Questions?

1-866-735-4137

Distributed By:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

PRINCIPLE DISPLAY PANEL - 4oz carton

NEW LOOK

Cetaphil®

OILY SKIN
DermaControlTM

Oil Absorbing
Moisturizer

30 BROAD SPECTRUM
     SPF 30 (UVA/UVB)
     SUNSCREEN

Clinically proven to reduce shine
and hydrate with less irritation 

Glycerin, Vitamins E & B5

AM

Dermatologist Recommended
Sensitive Skin

4 FL OZ (118 mL)

P57733-0

INGREDIENTS AND APPEARANCE

CETAPHIL OIL ABSORBING SPF 30 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Allantoin (UNII: 344S277G0Z)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Caprylyl Glycol (UNII: 00YIU5438U)
Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)
Ceramide Np (UNII: 4370DF050B)
Diisopropyl Sebacate (UNII: J8T3X564IH)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethiconol (2000 Cst) (UNII: T74O12AN6Y)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Enoxolone (UNII: P540XA09DR)
Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)
Panthenol (UNII: WV9CM0O67Z)
Pentylene Glycol (UNII: 50C1307PZG)
Phenoxyethanol (UNII: HIE492ZZ3T)
Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)
Polysorbate 61 (UNII: X9E1MY2JQG)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Sucrose Tristearate (UNII: 71I93STU5M)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)
Zinc Gluconate (UNII: U6WSN5SQ1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4134-00	1 in 1 CARTON	06/01/2022
1		118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 0299-4134-05	10 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4134)