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 firm2026-10-28

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 268 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands, LLC92fdea59-c19d-627a-e053-2995a90aabdc2024-11-25WarningsExact identifier
application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsExact identifier
application number: M020
MILKY MINERAL SUN SERUMTITANIUM DIOXIDE AND ZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity53834c89-b3b4-4e21-b9f6-19f95e78ba832024-11-21WarningsExact identifier
application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
application number: M020
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
application number: M020
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
application number: M020
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20ENSULIZOLENOXELL CORPORATION8528aa01-fd4b-58a6-e053-2991aa0a3d6a2024-11-20WarningsExact identifier
application number: M020
Facial Skin Shield Broad Spectrum SPF50 PlusAVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdbb62c700-be07-4fe3-b007-425a5f760b302024-11-20WarningsExact identifier
application number: M020
FOUNDATION LIGHT SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273ea785-241b-3e10-e063-6294a90a9fff2024-11-19WarningsExact identifier
application number: M020
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50ZINC OXIDEPOOLBARc081acef-9e1d-4aa6-b49c-c92fe28af2c72024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR1721023c-3321-4f0b-a053-6d0c657fa1b02024-11-19WarningsExact identifier
application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
application number: M020
Fresh Monster Mineral SunscreenZINC OXIDEBlue Zebra Brands, Inc.230cc36d-5163-f423-e063-6394a90a81242024-11-19WarningsExact identifier
application number: M020
Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades)OCTINOXATE AND TITANIUM DIOXIDENoxell356af30e-82c7-4e28-94bb-b536e74d01e12024-11-19WarningsExact identifier
application number: M020
Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades)TITANIUM DIOXIDENoxell Corporationfab59bd6-4ef6-4626-9f75-edcd4088e6432024-11-19WarningsExact 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