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 129 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Canopy UntintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC35824cd5-0036-7886-e063-6394a90ae6782025-12-12Exact identifier
application number: M020
Canopy SPF 40 TintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC358319c5-ae35-cb3b-e063-6394a90ad77f2025-12-12Exact identifier
application number: M020
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly358248e6-16cf-6f9b-e063-6394a90a55d72025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly35828e76-66db-49de-e063-6294a90a2b992025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly3592fd5f-13d1-9aec-e063-6394a90abd672025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly359371f2-2407-e1a1-e063-6294a90a21652025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397fc3c9-9d30-adcf-e063-6394a90ac7612025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39800bf1-e01a-e1c8-e063-6294a90a53bf2025-12-12Exact identifier
application number: M020
Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397130ea-dfad-ecd3-e063-6394a90a7da42025-12-12Exact identifier
application number: M020
Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39716532-a699-63b7-e063-6294a90aa0f02025-12-12Exact identifier
application number: M020
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
application number: M020
Simply Zinc Mineral Sunscreen TintedZINC OXIDESKIN BY NESRIN3580da4f-116d-8108-e063-6294a90a7bf42025-12-12Exact identifier
application number: M020
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
application number: M020
PROTECTOR SOLAR TINTED SPF SUNSCREENZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC3581d973-ac0b-7d2e-e063-6294a90ae2b32025-12-12Exact identifier
application number: M020
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
application number: M020
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation35920108-7f8a-27d4-e063-6294a90a0ef62025-12-12Exact identifier
application number: M020
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact 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