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
2027-12-31
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
2027-12-31

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 258 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30ZINC OXIDESaltyface Natural Incf0cc7ce9-81b3-439f-b5ee-96138de54e782024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
application number: M020
Costa Sea Mineral Sunscreen SPF 50ZINC OXIDECOSTA SEA INC841e1b3d-dbbc-4bb0-886a-fb2d077ae7392024-12-18WarningsExact identifier
application number: M020
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
application number: M020
Softlips Vanilla, Watermelon, CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company2235d029-157e-4a30-be90-605e6bc143fd2024-12-17WarningsExact identifier
application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
application number: M020
Softlips Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
application number: M020
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
application number: M020
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
application number: M020
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
application number: M020
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact 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