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 202 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
application number: M020
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
application number: M020
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020
Tulip Dew SHIELD GLOWZINC OXIDEBloomeffects, Inc.150f9660-48ec-a189-e063-6294a90a6d492025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3a9f94eb-98b7-5a20-e063-6394a90a173b2025-07-23WarningsExact identifier
application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a9fc050-f74f-a431-e063-6294a90ad4c22025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa3c442-26a6-0ab0-e063-6294a90a93a52025-07-23WarningsExact identifier
application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89106d-dbf0-e6ea-e063-6294a90a60f32025-07-22WarningsExact identifier
application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a898964-b4aa-e86d-e063-6394a90a34c62025-07-22WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal System KitAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3512c120-b8ba-ba59-e063-6394a90ac1e22025-07-22WarningsExact identifier
application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89d736-efef-088e-e063-6394a90a5e622025-07-22WarningsExact 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