FDA.reportPublic FDA data

Cetaphil

Product NDC
0299-3928
11-digit product format
002993928
Labeler code
0299
Product ID
0299-3928_8731dd5b-3ac1-42f8-b510-68f3e5104038
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-04-01
Substance
OCTOCRYLENE; AVOBENZONE
Active strength
10; 3 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cetaphil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a6bc3f2-4e52-252b-d051-94be1ee0cc00Available on FDA.report

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 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
OctocryleneACTIVE INGREDIENT5A68WGF6WMCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
AvobenzoneACTIVE MOIETYG63QQF2NOXCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
OctocryleneACTIVE MOIETY5A68WGF6WMCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Carbomer Copolymer Type AINACTIVE INGREDIENT71DD5V995LCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Carbomer Homopolymer Type CINACTIVE INGREDIENT4Q93RCW27ECETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Diisopropyl AdipateINACTIVE INGREDIENTP7E6YFV72XCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4CETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999RCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
TrolamineINACTIVE INGREDIENT9O3K93S3TKCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3
WaterINACTIVE INGREDIENT059QF0KO0RCETAPHIL (OCTOCRYLENE, AVOBENZONE) LOTION [GALDERMA LABORATORIES, L.P.]3

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

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 94 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 30(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Inc1273012a-107c-1b19-e063-6394a90a53e42025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e5bf2c-88c2-d346-e063-6394a90abc782025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb728a-8c11-d041-e063-6294a90abb552025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incc0421c97-72bd-fcac-e053-2995a90aac282025-12-31WarningsExact identifier
application number: M020
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incb6492438-5dd2-030e-e053-2a95a90a2f9f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdort Incca8d2e20-c1f1-ecf2-e053-2a95a90a790f2025-12-31WarningsExact identifier
application number: M020
Eucerin Tinted Age Defense Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc125d053c-9418-5772-e063-6294a90a6d6d2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 15 SunscreenAVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc4812da-0686-7789-e053-2995a90a561f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb6861830-fdad-3829-e053-2a95a90a09712025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0299-3928-04002993928041 BOTTLE, PUMP in 1 CARTON (0299-3928-04) / 118 mL in 1 BOTTLE, PUMP2000-04-010000-00-00NoNoCurrent