FDA.reportPublic FDA data

Complexion Correction Tinted Primer Sunscreen

Product NDC
85449-203
11-digit product format
854490203
Labeler code
85449
Product ID
85449-203_46009574-d84f-fac5-e063-6394a90a4ce3
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-08
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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
Complexion Correction Tinted Primer Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

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
357f2f62-904a-2234-e063-6394a90aee72Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85449-203-15Complexion Correction Tinted Primer Sunscreen1.5 g in 1 PACKETCREAM1.52
85449-203-50Complexion Correction Tinted Primer Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85449-203COMPLEXION CORRECTION TINTED PRIMER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]1Current NDC, 1 package rows20250521_357f2f62-904a-2234-e063-6394a90aee72.zip
85449-203COMPLEXION CORRECTION TINTED PRIMER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]1Current NDC, 1 package rows20250521_358021a2-235b-825b-e063-6394a90a76f5.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 235 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunceutical SPF 50 Mineral Glow SerumZINC OXIDEBaxter Laboratories Pty. Ltd.2c2c9b67-9588-efbe-e063-6294a90aa6a42025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
application number: M020
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50MINERAL SUNSCREENThe Center Brands, LLCcd35ae20-d5b7-479d-8a5e-0278eae9e83c2025-01-17WarningsExact identifier
application number: M020
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
application number: M020
Dolce and Gabbana Meet Your Flawless Matte Skin DuoOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDESocoplan3541c41b-f114-4734-a66f-be309ca6f3bf2025-01-16WarningsExact identifier
application number: M020
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
application number: M020
Snap On Racing Sunscreen KitAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGreater Pacific Industries, Inc.9f4f91d0-0fc5-43a3-be79-afce5afa2f952025-01-16WarningsExact identifier
application number: M020
Emme Diane Pure Protection Tinted Antioxidant SunscreenZINC OXIDEEmme Diane, Inc.b2b4daf5-765b-426d-8a72-9278f7cd43d72025-01-16WarningsExact identifier
application number: M020
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
application number: M020
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40ZINC OXIDESUNNY SAILOR LLC14ea2d11-c425-45d8-a23a-d4ed82a6439c2025-01-15WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30Hayden Caleel LLC00bf7331-c9dc-4a8a-9ff3-901e0d07eac62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc42f6f-4eaf-fa28-e063-6294a90a93fb2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEBlack Girl Sunscreen, LLC2bc419b3-4de2-7ed9-e063-6394a90a255f2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc47bd0-d81b-f1b9-e063-6394a90ad3752025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONEBlack Girl Sunscreen, LLC2bc46854-fe67-782b-e063-6294a90a79af2025-01-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85449-203-15854490203151.5 g in 1 PACKET (85449-203-15) 1.5 g2024-10-23YesNoCurrent
85449-203-508544902035053 g in 1 BOTTLE, PUMP (85449-203-50) 53 g2023-11-08NoNoCurrent