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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B Solutions SunscreenCOCONUT PINEAPPLE SCENTED SPF 50 STICKH.E.B29aef42c-f617-4c56-a166-8e1f0d6dbfd02021-07-09WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS58465981-e84c-4eaf-b7d5-fad1666f63fc2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 BambooOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASb2259b27-e1a5-482c-8916-356c1ee9774a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply BronzeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS199dde64-1dd3-4eb6-baef-261c97162f792021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 CremeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS753c34f2-3cb8-4df7-9aeb-ea926fb0279a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 DuneOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS745dd675-86ee-4acc-8333-4870e0a57c752021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 LatteOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASe66734e4-34e7-4674-bb98-bdca931a176d2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SandOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASbf78f7a7-93ca-425e-8571-175da6798e8e2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SepiaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS418cdd4a-23f7-4181-b734-5ab7456494a22021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ToffeeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS50138c51-f424-4b07-b3eb-c0d31d8ecf162021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 CameoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS01a861b9-0ab6-4c4c-a407-428a64509a1c2021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 BirchOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd5431d62-fded-4cdc-81a1-5b5e3eb928732021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 TawnyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS52c3378f-6b99-42fa-900e-8a693864c6152021-06-29WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenFACE SPF 70 LOTIONH.E.B73b49068-953b-496d-8ea9-404df7e790892021-01-19WarningsExact identifier
application number: M020
Think Every Day Face Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCafed91dd-8544-4b4b-e053-2995a90a2d162020-09-22WarningsExact identifier
application number: M020
THINKSPORT Kids sunscreen SPF 50ZINC OXIDEthinkOperations,LLC8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d2020-09-08WarningsExact identifier
application number: M020
THINKBABY Baby Sunscreen SPF 50ZINC OXIDEthinkOperations,LLC820317d2-1803-4949-bddf-09521a5d17502020-09-08WarningsExact identifier
application number: M020
THINKSPORT sunscreen SPF 50ZINC OXIDEthinkOperations,LLC6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea2020-08-03WarningsExact identifier
application number: M020
ESSENTIALS Face and Body SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsdfc44a01-e8fd-43fc-b3cd-5cac17e4a5a32020-04-02WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 18ZINC OXIDEthinkOperations,LLC9cd5010c-0b23-2888-e053-2995a90adb722020-01-23WarningsExact 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