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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact 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