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 154 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super Leaves Lip Balm SPF15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff1fc0-9ac5-2c9a-e063-6294a90a46322025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff5675-fd8d-b665-e063-6294a90a1e0b2025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 PineappleZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ffb35b-80f4-7ddb-e063-6394a90a2cbb2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Dewy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE7054144e0098c-170f-ca51-e063-6294a90aed202025-12-01WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Sun EssenceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e194cd-ea61-71b3-e063-6394a90ac4862025-12-01WarningsExact identifier
application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50ZINC OXIDEVenture Performance Inc630fc5c2-a315-4e26-9bd9-5f8533d759082025-12-01WarningsExact identifier
application number: M020
EMINENCE Red Currant Protective MoisturizerOCTINOXATE, ZINC OXIDEEminence Organic Skin Care7eca62af-6f70-44ec-879e-74712163c4e02025-12-01WarningsExact identifier
application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENECharlotte Tilbury Beauty Ltd.2b215ecb-7c3a-63db-e063-6394a90aa88f2025-12-01WarningsExact identifier
application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONELIFE WITHCORPORATION Inc.44ea9fb4-8e01-6969-e063-6294a90a6a942025-12-01WarningsExact identifier
application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENERoc Skincare2b3656d6-4b3a-9ef2-e063-6294a90acaa62025-12-01WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERare Beauty Brands Inc.44ec0db5-4437-e4a3-e063-6294a90a9a002025-12-01WarningsExact identifier
application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare2888a198-116b-8441-e063-6394a90a0f952025-12-01WarningsExact identifier
application number: M020
ReefSafe Very High Sun Protection sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ec619f-ed3b-2fd3-e063-6294a90a858b2025-12-01WarningsExact identifier
application number: M020
Reef safe - Face and Body sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38603298-e8da-e4c7-e063-6394a90aca3b2025-12-01WarningsExact identifier
application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44dd513e-ebaa-0d6a-e063-6394a90a78b72025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc0ae-a977-3adf-e063-6294a90a08982025-11-30WarningsExact identifier
application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44ddc4d8-3f3b-5d11-e063-6294a90ae88a2025-11-30WarningsExact identifier
application number: M020
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-NOCTINOXATE, ZINC OXIDEBEL STAR S Ab56f5883-be57-e0e5-e053-2a95a90adb0c2025-11-29WarningsExact 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