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 80 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIfc89d1b5-1ffe-4f06-8c5c-31f2eb0b56412026-01-14WarningsExact identifier
application number: M020
Oiana Mineral Sunscreen DropsZINC OXIDEOiana LLC4860257d-a8bf-7ce5-e063-6394a90a74db2026-01-14WarningsExact identifier
application number: M020
Standard Procedure Lip Balm SPF 50ZINC OXIDE HOMOSALATE OCTOCRYLENEStandard Procedure Inc1e3db995-b1c5-3a2e-e063-6294a90af75e2026-01-14WarningsExact identifier
application number: M020
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.48654406-505b-518b-e063-6394a90a5add2026-01-14WarningsExact identifier
application number: M020
JAYSUING Hyaluronic Acid Moisturizing SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.48662fae-2d41-4a4a-e063-6394a90a15222026-01-14WarningsExact identifier
application number: M020
CALIFORNIA ALOE FRESH POW DERY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENATURE REPUBLIC CO., LTD.aa10dbbf-97b3-4258-bbd3-0d8cc9935e122026-01-13WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4840f608-944a-3e3d-e063-6394a90a1d9d2026-01-13WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCb043f0f3-b263-4c49-86ca-9ecc71a22aa82026-01-13WarningsExact identifier
application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project SoothingHOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a60051-d57c-a341-e063-6394a90a92432026-01-13WarningsExact identifier
application number: M020
Sun GuardZINC OXIDESaje Natural Business Inc87ee593d-668c-f592-e053-2a95a90a17b12026-01-13WarningsExact identifier
application number: M020
Vixin Beach Face Sunscreen SPF50ZINC OXIDEVeganic SKN Limited482ae347-d175-52f2-e063-6394a90a92b02026-01-12WarningsExact identifier
application number: M020
FRE Glow ME Lightweight Tinted MoisturizerZINC OXIDEPeer Pharm Ltd1cf5b24a-e6fd-470a-e063-6294a90ab29c2026-01-12WarningsExact 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