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 10 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.574c96e9-77a2-778f-e063-6394a90a0aae2026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020
SKINSUIT FACE SPF 50ZINC OXIDESkin Authority LLC389fc528-fda5-485a-ab37-f99fcf3ed0b32026-07-23WarningsExact identifier
application number: M020
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
application number: M020
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3519e5bc-8c07-0617-e063-6394a90a65ae2026-07-22WarningsExact identifier
application number: M020
Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light NeutralAVOBENZONE, AND OCTISALATEThe Procter & Gamble Manufacturing Company366144c4-ec80-e435-e063-6394a90aba542026-07-22WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
application number: M020
YSE Beauty Instant Glow TrioAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6742e089-565a-40bc-8ffa-ec06e79860282026-07-21WarningsExact identifier
application number: M020
YSE Beauty The Roadies Packable AM RoutineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLCb0844331-d277-4cfb-957a-d8f9498836842026-07-21WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEBCM Cosmetique SAS328f96bc-fb68-33dc-e063-6294a90aecfa2026-07-21WarningsExact identifier
application number: M020
Sunscreen In the Raw SPF 50ZINC OXIDEBiomin LLC625523f0-366f-4148-b927-d726b7d1b9f42026-07-20WarningsExact identifier
application number: M020
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3a87ddee-241d-f972-e063-6294a90a7e892026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a893b13-e7f5-c5b1-e063-6394a90a42532026-07-20WarningsExact identifier
application number: M020
Omnilux Mineral Facial SunscreenZINC OXIDEThe Lotus Global Group, Inc, dba GlobalMed Technologies5710c84b-9d6b-da4d-e063-6394a90a07372026-07-20WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact 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