FDA.reportPublic FDA data

CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN

Product NDC
49967-150
11-digit product format
499670150
Labeler code
49967
Product ID
49967-150_f7fdf5ef-62b7-4263-b962-2f8a392da34c
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide and zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 50 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 DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal 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
8e94e203-d3cf-45a1-88f9-6999f0aab22bAvailable 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-150-01CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN75 mL in 1 TUBELOTION753
49967-150-01CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN1 in 1 CARTONLOTION13
49967-150-02CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN5 mL in 1 TUBELOTION53
49967-150-03CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN2.5 mL in 1 TUBELOTION2.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-150CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 4 package rows20240101_8e94e203-d3cf-45a1-88f9-6999f0aab22b.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 194 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCafc88e77-a4a1-49ec-b021-bb468fd0ac682025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD31049b45-0f5e-58b6-e063-6394a90ae52c2025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLCbd71a814-c0b4-428b-987e-72f7f55f998f2025-08-12WarningsExact identifier
application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCe9a88a57-5733-489d-a459-dd74c04daff22025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddae545-99db-144b-e063-6294a90adae52025-08-12WarningsExact identifier
application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aa05afb-c843-f38f-e063-6294a90a1cdf2025-08-12WarningsExact identifier
application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50OCTOCRYLENE, OCTISALATE, ZINC OXIDESun Bum, LLC390c6afd-e2be-414c-e063-6294a90ae1192025-08-12WarningsExact identifier
application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c32d2c0-0dbe-42e3-e063-6294a90aa9932025-08-12WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c342e57-cf85-b423-e063-6394a90a61b92025-08-12WarningsExact identifier
application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46ZINC OXIDE, OCTINOXATEDrmtlgy, LLC8e284afd-b90f-41d5-b334-e5cf4440b4d32025-08-12WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
application number: M020
ScarAid SPFSILICONE STICK WITH SPFBiodermis, LLC3c19063a-cdde-1bbe-e063-6294a90aa8a22025-08-11WarningsExact identifier
application number: M020
Pro-Sil SPFSILICONE STICK WITH SPFBiodermis, LLC3be06f82-935d-b1c2-e063-6294a90a953c2025-08-11WarningsExact identifier
application number: M020
Curology Daily MoisturizingAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECurology, Inc3c1967fc-bb89-2f7e-e063-6394a90a25122025-08-11WarningsExact identifier
application number: M020
ScarAid US SPFSILICONE STICK WITH SPFBiodermis, LLC3c196fa4-1bd3-7a43-e063-6294a90a4fb72025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-150-01499670150011 TUBE in 1 CARTON (49967-150-01) / 75 mL in 1 TUBE1 tube2019-02-010000-00-00NoNoCurrent
49967-150-02499670150025 mL in 1 TUBE (49967-150-02) 5 ml2019-02-010000-00-00NoNoCurrent
49967-150-03499670150032.5 mL in 1 TUBE (49967-150-03) 2.5 ml2019-02-01NoNoCurrent