FDA.reportPublic FDA data

SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50

Product NDC
49967-992
11-digit product format
499670992
Labeler code
49967
Product ID
49967-992_ea4a7d45-6c3e-497f-b5c1-0a498b1daf48
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
2024-05-01
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
80; 50; 50; 70 mg/mL; mg/mL; 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
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE80 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
817c882d-72f3-4ee7-8da2-a4a32f9d167fAvailable 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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 5030 mL in 1 JARLOTION301
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION11
49967-992-02SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 504 mL in 1 TUBELOTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-992SKINCEUTICALS CLEAR DAILY SOOTHING UV DEFENSE DAILY SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]1Current NDC, 3 package rows20240716_817c882d-72f3-4ee7-8da2-a4a32f9d167f.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 270 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC9751a700-5d51-357b-e053-2a95a90af66c2024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Face SPF30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc757b03-7e7d-b362-e053-2a95a90a84462024-10-27WarningsExact identifier
application number: M020
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5f9d56d-a80e-221c-e053-2a95a90aae922024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe53509bf-6bb7-2db7-e053-2a95a90aae182024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
application number: M020
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
application number: M020
Alumier MD Post Procedure Kit with HydrocortisoneTITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONEAlumier Labs2551d748-c3d6-cd18-e063-6294a90adab62024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
application number: M020
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unileverafe75aff-c056-eaf7-e053-2a95a90af71b2024-10-24WarningsExact identifier
application number: M020
Cancer Council Mineral Fluid SPF50ZINC OXIDEVitality US Co.1638f8a4-a2da-4e1f-e063-6294a90a03d92024-10-24WarningsExact identifier
application number: M020
Marlowe SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarlowe Holdings, LLCf94bd91a-f0ab-680c-e053-6394a90ac8552024-10-23WarningsExact identifier
application number: M020
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.2526eadf-4b55-ff81-e063-6394a90a3ba72024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneKREWD CLEAR SPF 50 CONTINUOUS SPRAYTenacious Holdings, Inc.55d99d0a-dc7f-4915-b7c1-f999c8b36e0d2024-10-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-992-01499670992011 JAR in 1 CARTON (49967-992-01) / 30 mL in 1 JAR1 jar2024-05-01NoNoCurrent
49967-992-02499670992024 mL in 1 TUBE (49967-992-02) 4 ml2024-05-01NoNoCurrent