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 firm2026-11-12

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 285 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Broad Spectrum SPF 40 Radiant Facial SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24114416-33b9-c6ba-e063-6394a90a6f3b2024-10-09WarningsExact identifier
application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0c40a46b-b9f9-8e14-e063-6394a90a95732024-10-09WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
application number: M020
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
application number: M020
IOPE UV DEFENSE SUN PROTECTORHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0f2a87f7-2185-16a5-e063-6294a90a92a32024-10-08WarningsExact identifier
application number: M020
Tropical Topical Matte SPF30ZINC OXIDEAllure Labs039fba4b-720a-9199-e063-6394a90adbfb2024-10-08WarningsExact identifier
application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0e746836-ed84-7b33-e063-6294a90aeff32024-10-08WarningsExact identifier
application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreenZINC OXIDEFallien Cosmeceuticals, LTD231af290-99ee-e94d-e063-6394a90a0bef2024-09-27WarningsExact identifier
application number: M020
Target Up and Up SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION23085ab9-5abb-a572-e063-6394a90ae34a2024-09-26WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and CeramidesHOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATION23598ad1-12a3-fe65-e063-6394a90a4f6f2024-09-26WarningsExact identifier
application number: M020
Target Up and Up SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION22f59a88-02d7-ebdb-e063-6394a90a957b2024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen StickZINC OXIDETARGET CORPORATION22f7c376-7289-04bf-e063-6394a90a14592024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide SunscreenZINC OXIDETARGET CORPORATION22f86630-d4b4-8ad7-e063-6394a90a8d1e2024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide SunscreenZINC OXIDETARGET CORPORATION22f9044a-f54c-b34b-e063-6394a90a88ee2024-09-25WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE ,OCTOCRYLENEEdgewell Personal Care Brands LLC22e2b447-bd6b-5e8a-e063-6394a90a0de92024-09-24WarningsExact identifier
application number: M020
Luminous Defense SPF 50ZINC OXIDELevels 2 Skin22e177b3-beea-212e-e063-6394a90a14522024-09-24WarningsExact identifier
application number: M020
Target Up and Up SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION22e359cd-4c63-b124-e063-6394a90aec732024-09-24WarningsExact 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