FDA.reportPublic FDA data

Cetaphil

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2024-04-16
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:11:09

Label at a glance#

ProductCetaphil
Active ingredientOCTOCRYLENE, AVOBENZONE
Label structure10 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 includin...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Avobenzone  3%
Octocrylene 10%

PURPOSE

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 sun glasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

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

PRINCIPAL DISPLAY PANEL - 4 FL OZ Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                    

P57752-0 new carton
P57752-0 new carton

NEW LOOK

Cetaphil®           

Daily Facial
Moisturizer
AM

15 BROAD SPECTRUM
     SPF 15 (UVA/UVB)
     SUNSCREEN

All Skin Types

Ultra lightweight lotion hydrates
and protects skin

Glycerin

Oil-Free

Recommended
Skin Cancer Foundation
Daily Use

4 FL OZ (118 mL)


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

All trademarks are the property of their respective owners.


Made in Canada

cetaphil.com
P57752-0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-3928-04Cetaphil1 in 1 CARTONLOTION110
0299-3928-04Cetaphil118 mL in 1 BOTTLE, PUMPLOTION11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-3928CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]10Current NDC, Legacy NDC, 2 package rows20240418_2a6bc3f2-4e52-252b-d051-94be1ee0cc00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-3928-04ML - Milliliter0299-3928293420d2-be3d-4985-a4d3-6d7bbf44a8cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX3
OctocryleneACTIVE INGREDIENT5A68WGF6WM3
AvobenzoneACTIVE MOIETYG63QQF2NOX3
OctocryleneACTIVE MOIETY5A68WGF6WM3
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBH3
Carbomer Copolymer Type AINACTIVE INGREDIENT71DD5V995L3
Carbomer Homopolymer Type CINACTIVE INGREDIENT4Q93RCW27E3
CyclomethiconeINACTIVE INGREDIENTNMQ347994Z3
Diisopropyl AdipateINACTIVE INGREDIENTP7E6YFV72X3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K3
GlycerinINACTIVE INGREDIENTPDC6A3C0OX3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE43
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T3
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999R3
TrolamineINACTIVE INGREDIENT9O3K93S3TK3
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-39280299-3928-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
Cyclomethicone 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
Poly(Methyl Methacrylate; 450000 Mw)Z47NNT4J11IACT
PhenoxyethanolHIE492ZZ3TIACT
Benzyl AlcoholLKG8494WBHIACT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.S)8Z5ZAL5H3VIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Carbomer Homopolymer, Unspecified Type0A5MM307FCIACT
Edetate Disodium7FLD91C86KIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XLOTION / TOPICAL250 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carbomer Copolymer Type ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyoxyl 100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyoxyl 100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XLOTION / TOPICAL250 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carbomer Homopolymer Type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carbomer Homopolymer Type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Carbomer Copolymer Type ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
CetaphilOCTOCRYLENE, AVOBENZONEGalderma Laboratories, L.P.2a6bc3f2-4e52-252b-d051-94be1ee0cc002024-04-16WarningsExact identifier
ndc (package): 0299-3928-04
ndc (product): 0299-3928
ndc11 (package): 00299392804
spl id: 8731dd5b-3ac1-42f8-b510-68f3e5104038
spl set id: 2a6bc3f2-4e52-252b-d051-94be1ee0cc00

Reported adverse events (FAERS/openFDA)#

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