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 316 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5169b10e-5a8d-479a-a6a8-1e7a13cb70c42023-12-12WarningsExact identifier
application number: M020
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDEBoscia LLCf76166f1-e987-4eaf-8192-14dc08c481f72023-12-12WarningsExact identifier
application number: M020
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBoscia LLC2a6b507f-0967-46e1-8360-0003772f1bdb2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated97bd2033-2cf0-4e5d-81e2-c453a1e3a65e2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE3LAB, Inc.703dc828-24b4-4f04-9f2c-4a2edfdf46322023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02TITANIUM DIOXIDE3LAB, Inc.7c6c7062-91f7-4304-98c3-f77967a2d3292023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated8a75dde9-8dcb-4f4a-b9df-88338bd2a4402023-12-12WarningsExact identifier
application number: M020
Everyday Facial Moisturizer And Sunscreen SPF 20ZINC OXIDE714 Essentials LTD3a29018b-8103-4983-b0c5-5f340775a05d2023-12-12WarningsExact identifier
application number: M020
Likewise Hand Moisturizer - Sun Protectant SPF 50OCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporateda54f0854-c55e-4a46-9084-16cb1be0f6812023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE3LAB, Incbd39d2fb-8326-4e19-b634-7a7308313d8a2023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 03TITANIUM DIOXIDE3LAB, Inc19884289-edb2-4d18-bd62-873533b94a102023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.92dc1a86-590e-4144-9d30-172645e631402023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 02TITANIUM DIOXIDE3LAB, Incbf4419b9-408d-469a-aa15-bbf419632f022023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Sunscreen SPF 50 Plus Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, Inc2bee6b87-c889-4ea1-87ad-e28949bcb67a2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily SkinTITANIUM DIOXIDE, ZINC OXIDELikewise Incorporated28b8c519-8417-427e-8d4f-94da44a69d9f2023-12-12WarningsExact identifier
application number: M020
BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c795f0-63bc-3033-e053-2995a90a55ab2023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.c06ecc56-2044-4396-8acd-6d18af9b984c2023-12-12WarningsExact identifier
application number: M020
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
application number: M020
Milani SPF BFF 30 PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONENew Milani Group, LLCc7a1f2a7-d299-2116-e053-2995a90ad8c52023-12-12WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENew Milani Group, LLC8f52f614-1cfe-4ef0-8cb6-37afbfddf44c2023-12-12WarningsExact 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