FDA.reportPublic FDA data

CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30

Product NDC
49967-346
11-digit product format
499670346
Labeler code
49967
Product ID
49967-346_3cd1453e-7f51-41ba-9d2f-75a352f1623c
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Octisalate, Octocrylene and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-19
Substance
HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
100; 50; 50; 20; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Facial Moisturizing with Sunscreen Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTINOXATE50 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE20 mg/mL
ZINC OXIDE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal 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
7d9e8c07-d295-4c8e-a52f-bdb509dc489bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-346-01CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-01CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3060 mL in 1 BOTTLELOTION602
49967-346-02CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3089 mL in 1 BOTTLELOTION892
49967-346-02CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-03CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 305 mL in 1 TUBELOTION52
49967-346-04CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301.5 mL in 1 PACKETLOTION1.52
49967-346-05CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-05CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3050 mL in 1 BOTTLELOTION502
49967-346-06CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30148 mL in 1 TUBELOTION1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-346CERAVE FACIAL MOISTURIZING WITH SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) LOTION [L’OREAL USA PRODUCTS INC]2Current NDC, 9 package rows20250328_7d9e8c07-d295-4c8e-a52f-bdb509dc489b.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 88 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC051b7413-8f1b-7135-e063-6294a90a93642026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ab90db-51bd-ffb3-e063-6294a90a852b2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ac28e7-41f1-bd4e-e063-6294a90a0e7b2026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-346-01499670346011 BOTTLE in 1 CARTON (49967-346-01) / 60 mL in 1 BOTTLE1 bottle2024-09-19NoNoCurrent
49967-346-02499670346021 BOTTLE in 1 CARTON (49967-346-02) / 89 mL in 1 BOTTLE1 bottle2024-09-19NoNoCurrent
49967-346-03499670346035 mL in 1 TUBE (49967-346-03) 5 ml2024-09-19NoNoCurrent
49967-346-04499670346041.5 mL in 1 PACKET (49967-346-04) 1.5 ml2024-09-19NoNoCurrent
49967-346-05499670346051 BOTTLE in 1 CARTON (49967-346-05) / 50 mL in 1 BOTTLE1 bottle2024-09-19NoNoCurrent
49967-346-0649967034606148 mL in 1 TUBE (49967-346-06) 148 ml2024-09-19NoNoCurrent