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 101 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Broad Spectrum SunscreenSPF 30 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLC69ac1218-76e6-04ff-e053-2a91aa0a40802025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen SprySPF 50 SUNSCREEN SPRAYSnugZ USA9390ea21-9f9f-14e2-e053-2a95a90ac5772025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Flavored Beeswax Lip BalmSPF 15 FLAVORED BEESWAX LIP BALMSnugZ/USA, LLC69bdfaaf-d49e-bf31-e053-2a91aa0affd32025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Broad Spectrum SunscreenSPF 50 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLCb7a3eed5-c8ca-ffda-e053-2a95a90a73bb2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Beeswax Lip BalmSPF 15 BEESWAX LIP BALMSnugZ/USA, LLC68816d3a-dbe9-7ce3-e053-2a91aa0a395e2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Soy Lip BalmSPF 30 SOY LIP BALMSnugZ/USA, LLC687ff49d-2d0e-2534-e053-2991aa0a28642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
application number: M020
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
application number: M020
OUHOE Bean SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d3b11f-93d9-0e38-e063-6294a90a41c32025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONEStriVectin Operating Company Inc.232cbde4-d8ea-4831-9b44-c2e93203260a2025-12-26WarningsExact identifier
application number: M020
CardonAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc72ee2c06-242e-29a2-e053-2991aa0ad8dc2025-12-26WarningsExact identifier
application number: M020
OUHOE Water-Permeable SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e63e1e-7851-ca26-e063-6394a90a9b532025-12-26WarningsExact identifier
application number: M020
OUHOE Sun MilkTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e678dd-13c5-b317-e063-6294a90aa9892025-12-26WarningsExact identifier
application number: M020
Dermatone Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - NaturalAVOBENZONE, OCTISALATE, OCTINOXATEIntelligent Elixirs, LLC287a61d8-0056-6211-e063-6394a90aa3da2025-12-24WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the faceHOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5997-d229-60ee-e063-6394a90a68db2025-12-23WarningsExact 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