FDA.reportPublic FDA data

Cetaphil PRO Oil Absorbing SPF 30

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2019-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:17:56

Label at a glance#

ProductCetaphil PRO Oil Absorbing SPF 30
Active ingredientOctocrylene, Octisalate, Avobenzone
Label structure8 sections

Dosage and administration

• 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients......Purpose

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%......Sunscreen
OCTISALATE 5%........Sunscreen
OCTOCRYLENE 7%....Sunscreen

Use(s)

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

P54130-2 PRO DermaControl Oil Absorbing SPF 30 Carton
P54130-2 PRO DermaControl Oil Absorbing SPF 30 Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-43130299-4313-04, 0299-4313-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octocrylene5A68WGF6WMACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Dimethicone92RU3N3Y1OIACT
Diisopropyl SebacateJ8T3X564IHIACT
Silicon DioxideETJ7Z6XBU4IACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT
Pentylene Glycol50C1307PZGIACT
Sodium Stearoyl Glutamate65A9F4P024IACT
PhenoxyethanolHIE492ZZ3TIACT
Caprylyl Glycol00YIU5438UIACT
EnoxoloneP540XA09DRIACT
PanthenolWV9CM0O67ZIACT
Trolamine9O3K93S3TKIACT
Allantoin344S277G0ZIACT
Potassium Sorbate1VPU26JZZ4IACT
Zinc GluconateU6WSN5SQ1ZIACT
Xanthan GumTTV12P4NEEIACT
Edetate Disodium7FLD91C86KIACT
Dimethiconol (2000 Cst)T74O12AN6YIACT
Hydroxypalmitoyl SphinganineNR33W2353TIACT
Isopropyl Lauroyl SarcosinateLYR06W430JIACT
Poly(methyl Methacrylate; 450000 Mw)Z47NNT4J11IACT
Polysorbate 61X9E1MY2JQGIACT
Sucrose Tristearate71I93STU5MIACT
Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked)F68VH75CJCIACT
.alpha.-tocopherolH4N855PNZ1IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
699c2b97-353a-468c-a16d-0a6279c23ce6e4d775b7-0ea4-4a71-91c9-f07e33638add2023-02-07WarningsExact identifier
spl set id: e4d775b7-0ea4-4a71-91c9-f07e33638add

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.