FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30

Product NDC
49967-360
11-digit product format
499670360
Labeler code
49967
Product ID
49967-360_911a65b0-aa5f-4526-8580-12adbfb726dd
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
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 Brightening with Sunscreen Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE50 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3676aa91-c90d-4a7a-b02e-d5b35304a04dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-360-01CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 3040 mL in 1 TUBELOTION401
49967-360-01CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION11

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 268 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Moisturizing UVLOCK Sun CushionZINC OXIDESEORIN COMPANY Co., Ltd.26407b83-b417-6450-e063-6294a90ad2b12024-11-06WarningsExact identifier
application number: M020
e.l.f. Holy Hydration Face Cream SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Incb7898d65-df86-580a-e053-2a95a90a5b1b2024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda604c-27cf-d500-e053-2995a90a5d652024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb92160-1749-d51b-e053-2995a90a9e872024-11-06WarningsExact identifier
application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb8513e-723b-b7d6-e053-2995a90aed522024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda9863-ad9f-e430-e053-2995a90a69a62024-11-06WarningsExact identifier
application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESEORIN COMPANY Co., Ltd.26442417-f238-1fc3-e063-6394a90a6f822024-11-06WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Face and BodyZINC OXIDEPierre Fabre USA Inc.fb5b1e94-bed3-8486-e053-6294a90a3a842024-11-06WarningsExact identifier
application number: M020
Avene Cleanance Mattifying SPF 30ZINC OXIDEPierre Fabre USA Inc.2644f545-0625-7858-e063-6394a90a59632024-11-06WarningsExact identifier
application number: M020
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
application number: M020
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
application number: M020
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50ZINC OXIDEKenvue Brands LLC8f34c1f6-51fe-4719-ba1f-1e23c05e937b2024-11-01WarningsExact identifier
application number: M020
Byoma Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEBYOMA LIMITED25de7939-3b18-7f9e-e063-6394a90a23a92024-11-01WarningsExact identifier
application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50ZINC OXIDEZO Skin Health, Inc.f218c158-19aa-ab90-e053-2a95a90aaef32024-10-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-360-01499670360011 TUBE in 1 CARTON (49967-360-01) / 40 mL in 1 TUBE1 tube2025-10-01NoNoCurrent