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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDICUBE PDRN SILKY SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC57154bec-6714-0314-e063-6294a90a4bd02026-07-20WarningsExact identifier
application number: M020
TOCOBO Double UV Defense SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON Co., Ltd.56aff65a-aa08-dc3f-e063-6294a90acac32026-07-19WarningsExact identifier
application number: M020
THE SPORTO Invisible Sport for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.46564a09-909d-bcc7-e063-6294a90a627b2026-07-17WarningsExact identifier
application number: M020
RR Sun CremeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Incdc60b685-a7fc-47bb-ade9-44a8e3b548122026-07-17WarningsExact identifier
application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.0ef2ebae-7198-47f4-8891-d1ca3cf54d4b2026-07-16WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
application number: M020
BaseLife Pure Mineral Shield SunscreenZINC OXIDEWintech America, Inc.7f741a91-6ed8-4d08-9196-d15527d044d52026-07-15WarningsExact identifier
application number: M020
BaseLife Clear UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWintech America, Inc.128db446-93ba-4347-bd39-66177572c6592026-07-15WarningsExact identifier
application number: M020
Biore Aqua Rich Facial Mist SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKao USA Inc.56a80a0d-b0b5-1098-e063-6294a90a52702026-07-15WarningsExact identifier
application number: M020
Anti Aging Lip Balm Pot SPF 15LIP BALMEpicuren Disocovery4097e28a-ed11-e16a-e063-6294a90a5e9b2026-07-14WarningsExact identifier
application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50ZINC OXIDECALM ENTERPRISE LLC722462d8-d2ab-44ce-9065-673ab20762692026-07-14WarningsExact identifier
application number: M020
X-Treme Cream Propolis Sunscreen SPF 45X-TREME CREAMEpicuren Discovery3b29976e-eee0-b978-e063-6294a90accd62026-07-14WarningsExact identifier
application number: M020
Anti-Aging Lip Balm SPF 15LIP BALMEpicuren Discovery3cbd0550-b6e5-3e86-e063-6394a90ac07f2026-07-14WarningsExact identifier
application number: M020
Zinc Oxide Perfecting SunscreenZINC OXIDEEpicuren Discovery1a0228f9-bf3f-a1fe-e063-6294a90a3fb52026-07-14WarningsExact identifier
application number: M020
Vacation FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.14b8a3cf-031c-4c52-ba81-e683e69d0f372026-07-14WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEL. Perrigo Companybd5c9df7-8dfb-4d20-9966-e148c5667b222026-07-14WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC4081a4ad-b738-5fb6-e063-6394a90a91712026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc5c1d8-91f8-8ad2-e063-6294a90a92292026-07-13WarningsExact identifier
application number: M020
Olay Super Serum Body Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company5513c5e2-3baf-2f09-e063-6394a90a495a2026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc48592-f70d-664e-e063-6294a90ac6e82026-07-13WarningsExact 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