FDA.reportPublic FDA data

Cetaphil Daily Facial Moisturizer with suncreen SPF 35

Product NDC
0299-4113
11-digit product format
002994113
Labeler code
0299
Product ID
0299-4113_2b6cf05c-6176-47b7-8a9d-a9649ddfd633
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
28; 95; 48; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0299-41130299-4113-05DDiscontinued by firm2026-11-13

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 Daily Facial Moisturizer with suncreen SPF 35
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE28 mg/mL
HOMOSALATE95 mg/mL
OCTISALATE48 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5eb347f-0d46-4de6-8f3f-9010327678edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4113-05Cetaphil Daily Facial Moisturizer with suncreen SPF 351 in 1 CARTONLOTION14
0299-4113-05Cetaphil Daily Facial Moisturizer with suncreen SPF 3588 mL in 1 BOTTLE, PUMPLOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4113CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [GALDERMA LABORATORIES, L.P.]4Current NDC, Legacy NDC, 2 package rows20231117_f5eb347f-0d46-4de6-8f3f-9010327678ed.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 334 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1OCTINOXATE, OXYBENZONEAmway Corpd810bbe7-a889-4737-9a78-d996fec711222023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1OCTINOXATE, OXYBENZONEAmway Corp0039ca4d-2a0c-4b19-a029-1c080fc292ce2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1OCTINOXATE, OXYBENZONEAmway Corp410592f1-57f5-4c17-8162-a0c088f0bf272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1OCTINOXATE, OXYBENZONEAmway Corpe4e61943-ec96-467c-8921-ee531ef4f13d2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1OCTINOXATE, OXYBENZONEAmway Corp62ff0eea-b67e-476c-b7f2-0fcaed9dc2272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1OCTINOXATE, OXYBENZONEAmway Corp179e5268-8eca-40b7-aa7f-ede221fa9c892023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1OCTINOXATE, OXYBENZONEAmway Corp8a3fcfaa-5bfa-4f77-932f-bfb75628c9c62023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1OCTINOXATE, OXYBENZONEAmway Corp18c11289-9cc0-4a37-a299-ee3c358dbeca2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1OCTINOXATE, OXYBENZONEAmway Corpd7cb8e53-a36f-43d1-9918-f5680aafb2c42023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2OCTINOXATE, OXYBENZONEAmway Corp01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f52023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1OCTINOXATE, OXYBENZONEAmway Corpff9c6565-a942-494f-af8c-557974675db82023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1OCTINOXATE, OXYBENZONEAmway Corp9ca531ae-10b5-4791-b62c-37b99bc1d4ea2023-10-23WarningsExact identifier
application number: M020
g and h Protect BodyENSULIZOLE, OCTISALATE, ZINC OXIDEAccess Business Group LLC03768ff4-0c67-48b3-a2f3-321d0a6790e82023-10-23WarningsExact identifier
application number: M020
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
application number: M020
Coconut SPF 15 Broad Spectrum Lip BalmCOCONUT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d28eb-2f41-7146-e053-2a95a90a86722023-10-23WarningsExact identifier
application number: M020
Bubblegum SPF 15 Broad Spectrum Lip BalmBUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7590383-661f-5b1e-e053-2995a90a197e2023-10-23WarningsExact identifier
application number: M020
Blackberry Smoothie SPF 15 Broad Spectrum Lip BalmBLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7577d5f-69d8-3f32-e053-2995a90aaba52023-10-23WarningsExact identifier
application number: M020
Breath Fresh SPF 15 Broad Spectrum Lip BalmBREATH FRESH SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c3a62f-5c11-c78c-e053-2a95a90a3a582023-10-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-4113-00002994113001 BOTTLE, PUMP in 1 CARTON (0299-4113-00) / 88 mL in 1 BOTTLE, PUMP2026-08-01NoNoCurrent
0299-4113-05002994113051 BOTTLE, PUMP in 1 CARTON (0299-4113-05) > 88 mL in 1 BOTTLE, PUMP2020-11-010000-00-00NoNoCurrent
0299-4113-100029941131010 mL in 1 TUBE (0299-4113-10) 10 ml2026-08-27YesNoCurrent