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 146 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
application number: M020
Skin Filter Glow SPFZINC OXIDEMALORIE MILES36485f44-a6bd-9529-e063-6294a90af7a42025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES36499be5-d680-92bf-e063-6394a90a89db2025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES364ae392-480a-14ea-e063-6394a90a38832025-12-08Exact identifier
application number: M020
Personalized Moisturizer SPF 30ZINC OXIDE 10.00%Proven Skincared3cf8f81-d6ae-4570-ad86-43415e973e132025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2f9d087c-b2b3-5654-e063-6294a90a94e52025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faee7ef-fc0c-6d01-e063-6294a90a6d682025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faf530d-5574-b702-e063-6294a90ad6fd2025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2fb00db0-4c37-56c6-e063-6294a90a8aff2025-12-08WarningsExact identifier
application number: M020
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334bf8ea-2485-84e8-e063-6294a90aefa62025-12-08Exact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334e32a4-c3a5-e37d-e063-6294a90ad6cf2025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
application number: M020
Mineral Based Facial SunscreenZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3e8981ed-5847-7009-e063-6394a90a49a12025-12-08WarningsExact identifier
application number: M020
Replenishing Daily Protection Sunscreen InvisibleZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32462e88-0e74-a675-e063-6294a90ac5642025-12-08Exact 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