FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula

Product NDC
49967-832
11-digit product format
499670832
Labeler code
49967
Product ID
49967-832_97f682ae-8958-4ce4-9fe7-30ca215087d5
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, 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
2022-10-10
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
60; 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 Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE60 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL
ZINC OXIDE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal 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
cd69df67-5231-4a75-a9fb-a8669806a892Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-832-01CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula89 mL in 1 TUBELOTION893
49967-832-01CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula1 in 1 CARTONLOTION13
49967-832-02CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula5 mL in 1 TUBELOTION53
49967-832-03CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula150 mL in 1 TUBELOTION1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-832CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SHEER SUNSCREEN BROAD SPECTRUM SPF 30 FACE AND BODY WATER RESISTANT 80 MINUTES HYBRID FORMULA (HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS, INC.]2Current NDC, Legacy NDC, 4 package rows20231229_cd69df67-5231-4a75-a9fb-a8669806a892.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 116 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
application number: M020
Daily Protect Mineral SunscreenZINC OXIDESARAH'S4617beb7-381e-8994-e063-6394a90a14b52025-12-16WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation18ed9b7f-bdbe-45d7-a38c-6d065080ae992025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
application number: M020
b.tan Beach Please SPF 7AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbdc07d83-a34f-5262-e053-2995a90acfc32025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S461910bd-1f74-f99e-e063-6394a90ae30e2025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S4619b08f-3e63-25aa-e063-6294a90a78d72025-12-16WarningsExact identifier
application number: M020
megALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48Meg Cosmetics Inc4526bacf-6451-b297-e063-6294a90af71a2025-12-16WarningsExact identifier
application number: M020
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32ZINC OXIDEOnekind.25c11197f4-cee0-04b3-e053-2995a90a1ba82025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium DeepZINC OXIDECrunchi, LLC.69618265-2ebb-4cdc-a28f-e36c07fe5b8f2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 MediumZINC OXIDECrunchi, LLC.23248bc3-1b82-443a-b38a-df7f0efb5d2a2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 LightZINC OXIDECrunchi, LLC.cf4039f5-00ee-4227-a3dc-61995c8001352025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Body Sunscreen SPF 30ZINC OXIDECrunchi, LLC.227f5a41-8c3c-492d-947f-e2b046208bca2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light MediumZINC OXIDECrunchi, LLC.5b3f2766-065b-4817-a5ff-bd1c7882bfc92025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30ZINC OXIDECruchi, LLC.4f3bcfa0-e43e-4284-afaa-6488ddd749f02025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-832-01499670832011 TUBE in 1 CARTON (49967-832-01) / 89 mL in 1 TUBE1 tube2022-10-100000-00-00NoNoCurrent
49967-832-02499670832025 mL in 1 TUBE (49967-832-02) 5 ml2022-10-10NoNoCurrent
49967-832-0349967083203150 mL in 1 TUBE (49967-832-03) 150 ml2024-10-01NoNoCurrent