FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day

Product NDC
49967-900
11-digit product format
499670900
Labeler code
49967
Product ID
49967-900_246b0293-ab86-44b4-b615-fef215ef0ce7
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate and zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-28
Substance
OCTINOXATE; ZINC OXIDE
Active strength
75; 105 mg/g; mg/g
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
CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
ZINC OXIDE105 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal 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
50542a3b-2ef0-452f-b463-79b41e10d1e0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-900-01CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day1 in 1 CARTONCREAM14
49967-900-01CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day50 g in 1 BOTTLE, PUMPCREAM504
49967-900-02CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day5 g in 1 TUBECREAM54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-900CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BROAD SPECTRUM SPF 30 DAY (OCTINOXATE AND ZINC OXIDE) CREAM [L'OREAL USA PRODUCTS INC.]4Current NDC, Legacy NDC, 3 package rows20240101_50542a3b-2ef0-452f-b463-79b41e10d1e0.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 160 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c77b48-18fb-3efe-e063-6294a90ade4b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c784ce-3a54-5416-e063-6294a90ac9a22025-11-17WarningsExact identifier
application number: M020
Daily Essential Face MoisturizerZINC OXIDESolarium Brands LLC2a92edc1-04ac-3eda-e063-6294a90ad46d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Eye CreamTITANIUM DIOXIDE, ZINC OXIDESolarium Brands LLC2a931d9f-4ba8-e3a5-e063-6294a90af7802025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Blushing NudeZINC OXIDESolarium Brands LLC2a93998c-185b-9207-e063-6294a90ab0e92025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Skin Perfecting PrimerZINC OXIDESolarium Brands LLC302a02d1-3dc5-2745-e063-6394a90ab6d22025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Luminizing Glow DropsZINC OXIDESolarium Brands LLC302a4efe-d429-b1c4-e063-6294a90a073d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Dusty RoseZINC OXIDESolarium Brands LLC2a934860-02a7-a463-e063-6294a90aa4462025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Scarlet BloomZINC OXIDESolarium Brands LLC2a931e78-e58c-e216-e063-6294a90a3e492025-11-17WarningsExact identifier
application number: M020
Morning Person Daily Repair Protect MoisturizerZINC OXIDEMorning Person Beauty33a20264-9216-154e-e063-6294a90a3c8b2025-11-17WarningsExact identifier
application number: M020
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUSHOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands LLCc780d5cf-8388-42e0-e053-2a95a90a7c042025-11-17WarningsExact identifier
application number: M020
Hell on Earth The Resistance Daily Face MoisturizerTITANIUM DIOXIDE, ZINC OXIDEHell on Earth38debebf-1e12-09f3-e063-6294a90a9a2a2025-11-17WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe64de59e-b8db-522e-e053-2a95a90ac4582025-11-17WarningsExact identifier
application number: M020
Credo Skin Solar Limits SerumZINC OXIDEEco-Chic LLC395dc8eb-978b-a18f-e063-6294a90a22072025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ce5223-3fb2-4c27-e063-6394a90a8a8f2025-11-17WarningsExact identifier
application number: M020
Credo Follain Daily Mineral SunscreenZINC OXIDEEco-Chic LLC395d6ad4-04ae-8945-e063-6294a90ad87c2025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c7b7571-7317-98bc-e063-6294a90aa29f2025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC22717885-d06b-ed2d-e063-6294a90a21182025-11-17WarningsExact identifier
application number: M020
Riversol Daily Glow Mineral TintedZINC OXIDERiversol Skincare3bc7d94e-e312-a9ca-e063-6394a90a43382025-11-17WarningsExact identifier
application number: M020
Riversol Daily Glow Mineral UntintedZINC OXIDERiversol Skincare3bc78cbb-83e3-7fd6-e063-6394a90a52602025-11-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-900-01499670900011 BOTTLE, PUMP in 1 CARTON (49967-900-01) / 50 g in 1 BOTTLE, PUMP2017-08-280000-00-00NoNoCurrent
49967-900-02499670900025 g in 1 TUBE (49967-900-02) 5 g2017-08-280000-00-00NoNoCurrent