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 260 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHAVA Protecting Body Broad Spectrum SPF 30AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltde188c328-3617-4f02-8bc9-47976acf37112024-12-17WarningsExact identifier
application number: M020
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer TintTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inca1cab79d-0151-49ee-86dc-c2739842e62e2024-12-17WarningsExact identifier
application number: M020
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
application number: M020
Even Up Sunscreen SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef9d375af-3c8b-4462-b729-fdd4be9292842024-12-17WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d842103-7157-793a-e063-6394a90a6feb2024-12-16WarningsExact identifier
application number: M020
SPF15 natural lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.295f2a15-19fa-011f-e063-6394a90aea7b2024-12-16WarningsExact identifier
application number: M020
BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15AVOBENZONE, OCTINOXATE, AND OCTISALATEBobbi Brown Professional Cosmetics Inc.4bfbfac7-6738-4996-a152-95dfbd7591542024-12-16WarningsExact identifier
application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.dc6b28ca-b922-460a-8028-fb3f5afdbe9d2024-12-16WarningsExact identifier
application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.1f9a4b71-45aa-4156-9fe6-ffa81f808a852024-12-16WarningsExact identifier
application number: M020
AHAVA Protecting Moisturizing SPF50AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd7502e06d-754b-4cb8-ba4c-91eee04539322024-12-16WarningsExact identifier
application number: M020
Natural Finish Pressed Foundation SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColoresciencec389e183-bfad-4813-af09-fae3aa05e82a2024-12-16WarningsExact identifier
application number: M020
Sunforgettable Total Protection Brush-On Shield SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencec77357f1-7ada-4325-86f7-5ee801610f422024-12-16WarningsExact identifier
application number: M020
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30ZINC OXIDEColorescience5b6f906e-6620-48b0-9c39-0eb1c8dc1c632024-12-16WarningsExact identifier
application number: M020
Ryshi SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Rite Aide313350f-74d9-370b-e053-2995a90aeeaf2024-12-15WarningsExact identifier
application number: M020
Annmarie SPF 20 SunscreenZINC OXIDE 15%Annmarie Gianni Skin Care LLCcc722ce1-0ded-19d5-e053-2995a90a7d032024-12-15WarningsExact identifier
application number: M020
Zinka SPF 30 Clear SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Zinka, Incc054ac39-d03f-17c1-e053-2a95a90aa5ef2024-12-15WarningsExact identifier
application number: M020
QC SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%CDMAf82080b1-ef90-a027-e053-6294a90a19f22024-12-15WarningsExact identifier
application number: M020
QC SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%CDMAf80ceb05-0bd4-1355-e053-6294a90afb192024-12-15WarningsExact identifier
application number: M020
Lip Shine SPF35 SunscreenZINC OXIDEColorescience3a6506c4-1ba9-493a-a4c8-e5f9c60d221b2024-12-13WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPZINC OXIDECOSMAX USA, CORPORATION292165af-545d-db43-e063-6394a90ad1832024-12-13WarningsExact 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