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 firm2026-10-27

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 229 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quick Screen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Quick Flick PTY LTD3788666e-7efa-43da-95f5-6218b7fcb6ea2025-02-12WarningsExact identifier
application number: M020
Dolce AND Gabbana Get Your Healthy Glowy SkinZINC OXIDESocoplan91bf1cca-8d18-4c59-864d-4fd0619c67132025-02-12WarningsExact identifier
application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dfd1f99-5896-1e0f-e063-6394a90aa71d2025-02-12WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf9024581-dbab-b7cb-e053-6294a90a8b9a2025-02-12WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLCebdaf6c1-1572-4840-851b-6d780471fcb22025-02-11WarningsExact identifier
application number: M020
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
application number: M020
Beeswax SPF 15 Broad Spectrum Lip BalmBEESWAX SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc2dcc2f9b-4a8c-b281-e063-6294a90ad9d62025-02-10WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc2dcca380-c0e4-4e04-e063-6394a90ac31e2025-02-10WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2dd5ea23-eee6-5d14-e063-6294a90a0fd32025-02-10WarningsExact identifier
application number: M020
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc25afb-a171-f1f2-e063-6294a90ae3332025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc285ad-08cd-14e6-e063-6294a90a24fc2025-02-09WarningsExact identifier
application number: M020
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
application number: M020
NIA 24 SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENENiadyne Ince5c9d56f-48b4-4f0e-add6-f73268755b162025-02-07WarningsExact identifier
application number: M020
Pacific Mango Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANYd09e3096-0678-4433-a555-61f18a45873b2025-02-06WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact 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