FDA.reportPublic FDA data

Cetaphil Hydrating Face Sunscreen SPF 35

Product NDC
0299-4142
11-digit product format
002994142
Labeler code
0299
Product ID
0299-4142_6eb7c1fe-9c87-4330-a245-e20a0f66aa56
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
2023-11-01
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
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 Hydrating Face Sunscreen SPF 35
Listing expiration
2026-12-31

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
e924bfd5-d64d-4918-b57b-7d4da28bd013Available 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
0299-4142-00Cetaphil Hydrating Face Sunscreen SPF 351 in 1 CARTONLOTION11
0299-4142-00Cetaphil Hydrating Face Sunscreen SPF 3588 mL in 1 BOTTLE, PUMPLOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4142CETAPHIL HYDRATING FACE SUNSCREEN SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [GALDERMA LABORATORIES, L.P.]1Current NDC, 2 package rows20231101_e924bfd5-d64d-4918-b57b-7d4da28bd013.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 339 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peppermint SPF 15 Broad Spectrum Lip BalmPEPPERMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901a7f7-af83-0aa1-e053-2995a90aa32b2023-10-18WarningsExact identifier
application number: M020
Mineral SPF 15 Broad Spectrum Lip BalmMINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc44d2759a-d95d-7525-e054-00144ff88e882023-10-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d2023-10-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productiond60887aa-7586-4d4b-88af-35b4f982aacf2023-10-18WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Protection SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLCd13da7be-a419-4416-96be-8421665dbd822023-10-17WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALMRaining Roseefe27e7e-e805-1c47-e053-2995a90af22e2023-10-17WarningsExact identifier
application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25AVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLCf1109f0e-ebf5-450e-8a4e-b314a91b24832023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC8c7c0e3f-6092-413c-90f1-b3466c8a95012023-10-13WarningsExact identifier
application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar SmartOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC3d23406b-5252-4ab0-b666-77c0132b0d002023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC94274343-3892-4c27-9d2f-c025310e29592023-10-13WarningsExact identifier
application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGYOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCe557e7f3-1fa7-4dde-977f-fe3f942496c02023-10-13WarningsExact identifier
application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC68cfcbc2-a214-437e-9956-f77c90d748882023-10-13WarningsExact identifier
application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC159410d4-4479-4442-b371-bde72aae3e1e2023-10-13WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-ProtectionHOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDELaboratoires Clarins0695e3a4-0e8f-419e-b128-9b02bdb8b02a2023-10-11WarningsExact identifier
application number: M020
Orange Soda SPF 15 Broad Spectrum Lip BalmORANGE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c362ae-b878-c630-e053-2995a90ad4c42023-10-10WarningsExact identifier
application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVBZINC OXIDESkin Laundry Holdings, Inc.071038d9-8179-6953-e063-6394a90a8a842023-10-06WarningsExact identifier
application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST4bae83b7-2c98-4928-8e71-bb4f19cc48f02023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 LightZINC OXIDE TITANIUM DIOXIDEBurt's Bees3150ef71-2ea1-25d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 MediumZINC OXIDE TITANIUM DIOXIDEBurt's Bees3346f41e-32d0-35d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC59eeb180-1ac6-44b3-9742-dc65287896bf2023-10-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0299-4142-00002994142001 BOTTLE, PUMP in 1 CARTON (0299-4142-00) / 88 mL in 1 BOTTLE, PUMP2023-11-01NoNoCurrent