FDA.reportPublic FDA data

Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40

Product NDC
0299-4138
11-digit product format
002994138
Labeler code
0299
Product ID
0299-4138_829abf53-a054-4ec4-9003-c97dc11893cd
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide, zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-20
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
101; 78 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage0299-41380299-4138-05DDiscontinued by firm2026-11-13

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0299-41380299-4138-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE101 mg/mL
ZINC OXIDE78 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45d101be-2b88-4759-9ccc-556f5ec0553dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4138-00Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 4050 mL in 1 TUBECREAM504
0299-4138-00Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 401 in 1 CARTONCREAM14
0299-4138-05Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 4010 mL in 1 TUBECREAM104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4138CETAPHIL REDNESS RELIEVING DAILY FACIAL MOISTURIZER WITH SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [GALDERMA LABORATORIES, L.P.]3Current NDC, 3 package rows20241116_45d101be-2b88-4759-9ccc-556f5ec0553d.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 248 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edc9-1ebd-e063-6294a90aee132024-12-25WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION29fe531e-2ade-170f-e063-6394a90a13962024-12-24WarningsExact identifier
application number: M020
SOLAR MILK SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION29fe4dad-d1fb-e750-e063-6294a90ab3072024-12-24WarningsExact identifier
application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Incd30cc344-846d-416e-ac57-4a29d4ed82632024-12-24WarningsExact identifier
application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15ZINC OXIDE, TITANIUM DIOXIDE MAKE-UPAlmay, Inc.281557c0-e668-4436-86a7-3f583091e4e42024-12-24WarningsExact identifier
application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcc-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38b-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 HazelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38c-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b48b8-5953-9ab7-e063-6394a90a6b242024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcd-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich MahoganyFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-883b-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light TanFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b557a-ff60-f33f-e063-6394a90ac66f2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-8839-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b668d-036e-893e-e063-6294a90a82af2024-12-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0299-4138-00002994138001 TUBE in 1 CARTON (0299-4138-00) / 50 mL in 1 TUBE1 tube2023-07-20NoNoCurrent
0299-4138-050029941380510 mL in 1 TUBE10 mlHistorical