FDA.reportPublic FDA data

CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN

Product NDC
49527-041
11-digit product format
495270041
Labeler code
49527
Product ID
49527-041_2a148cdc-cfc1-9dc4-e063-6394a90ae5d0
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, and AVOBENZONE
Dosage form
STICK
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-01
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
5; 5; 3 g/100g; g/100g; g/100g
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
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 g/100g
OCTISALATE5 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-041-012022-08-04C16284748780-1e4f33bdf-a388-d8a0-e053-dadaa90a6e4eCLINIQUE TARGETED PROTECTION STICK SPF 45 BROAD SPECTRUM SUNSCREEN
49527-041-012022-07-29C16284748780-1e4f33bdf-a388-d8a0-e053-dadaa90a6e4eCLINIQUE TARGETED PROTECTION STICK SPF 45 BROAD SPECTRUM SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-041-01CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN1 in 1 CARTONSTICK19
49527-041-01CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN6 g in 1 CYLINDERSTICK69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D3CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
cetyl ricinoleateINACTIVE INGREDIENT1P677500YDCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
jojoba butterINACTIVE INGREDIENTXIA46H803RCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
phenyl trimethiconeINACTIVE INGREDIENTDR0K5NOJ4RCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
tocopherolINACTIVE INGREDIENTR0ZB2556P8CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VCLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-041CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN (HOMOSALATE, OCTISALATE, AND AVOBENZONE) STICK [CLINIQUE LABORATORIES LLC]9Current NDC, Legacy NDC, 2 package rows20241226_f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444.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 96 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Sport Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd46052d3-6f45-5f4d-e053-2995a90a87602025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-041-01495270041011 CYLINDER in 1 CARTON (49527-041-01) / 6 g in 1 CYLINDER1 cylinder2008-12-010000-00-00NoNoCurrent