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 74 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANUA INVISIBLE MATTE FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.4248deaf-ad55-a9b4-e063-6294a90a55cc2026-01-19WarningsExact identifier
application number: M020
ONSART Mineral SunscreenZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.48c9d08d-9a91-7df5-e063-6294a90a1c4a2026-01-19WarningsExact identifier
application number: M020
Intense Moisture Day CreamAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECVS Health795d3546-f0dd-4b54-9807-9cdb3e6261812026-01-19WarningsExact identifier
application number: M020
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
application number: M020
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Berry SPF 30PREQUEL LIP VISOR BERRY SPF 30The Center Brands, LLCe4f3a0eb-4a8c-4145-92e4-979f03e3a5112026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Blush SPF 30PREQUEL LIP VISOR BLUSH SPF 30The Center Brands, LLCbc681245-e158-4cfa-9718-7ec4cff0e60d2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Mahogany SPF 30PREQUEL LIP VISOR MAHOGANY SPF 30The Center Brands, LLCea8dcd14-3c54-46a6-aabc-3655f051065b2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Nude SPF 30PREQUEL LIP VISOR NUDE SPF 30The Center Brands, LLC03a7c77d-7b6e-4720-88f1-492ce57c71452026-01-16WarningsExact identifier
application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30ZINC OXIDECVL Cosmetics North America Incf3057856-1461-41d3-a5c4-9f12e3a4a0ee2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact 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