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

Cetaphil PRO Oil Absorbing SPF 30 by

Drug Labeling and Warnings

Cetaphil PRO 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......Purpose

AVOBENZONE 3%......Sunscreen
OCTISALATE 5%........Sunscreen
OCTOCRYLENE 7%....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, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Hydroxypalmitoyl Sphinganine (Ceramide), Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Triethanolamine, 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.
Fort Worth, TX 76177

All trademarks are the property of their respective owners

Made in Canada

Cetaphil.com

PRINCIPLE DISPLAY PANEL - 4oz

Cetaphil®

PRO

DERMACONTROLTM

Oil Absorbing

Moisturizer                 

with Sunscreen

BROAD SPECTRUM SPF 30

Oil free, lightweight moisturizer won't clog pores

Clinically proven to absorb excess oil and reduce shine

Protects against damaging UVA & UVB rays

4 FL OZ (118 mL)

[SEAL]

Recommended

Skin Cancer Foundation

DAILY USE

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4313
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Diisopropyl Sebacate (UNII: J8T3X564IH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Pentylene Glycol (UNII: 50C1307PZG)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Enoxolone (UNII: P540XA09DR)
Panthenol (UNII: WV9CM0O67Z)
Trolamine (UNII: 9O3K93S3TK)
Allantoin (UNII: 344S277G0Z)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Dimethiconol (2000 Cst) (UNII: T74O12AN6Y)
Hydroxypalmitoyl Sphinganine (UNII: NR33W2353T)
Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)
Poly(methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)
Polysorbate 61 (UNII: X9E1MY2JQG)
Sucrose Tristearate (UNII: 71I93STU5M)
Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)
.alpha.-tocopherol (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4313-04	1 in 1 CARTON	12/01/2011
1		118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 0299-4313-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(0299-4313)