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 122 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Mineral Zinc Oxide SPF 40ZINC OXIDESpalina LLC.35aa74c5-1bb3-9814-e063-6294a90a69992025-12-15Exact identifier
application number: M020
Mineral Tinted SPF40 with ceramidesZINC OXIDESpalina LLC.35ac3bd1-a4c1-5078-e063-6394a90afdc82025-12-15Exact identifier
application number: M020
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
application number: M020
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
application number: M020
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
application number: M020
20Percent Zinc Total ProtectionZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bcaee1-001b-82da-e063-6394a90a4a0f2025-12-15Exact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
application number: M020
Protection E And C Lightly TintedZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bce44e-d9f1-9279-e063-6394a90a64532025-12-15Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
application number: M020
Glow ShieldZINC OXIDEKristina Lerner35be8766-1352-8967-e063-6294a90a896a2025-12-15Exact identifier
application number: M020
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
application number: M020
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
application number: M020
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact 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