FDA.reportPublic FDA data

Tinted Sunscreen

Product NDC
85331-203
11-digit product format
853310203
Labeler code
85331
Product ID
85331-203_45af23fa-cc5a-1a7e-e063-6394a90acf71
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Scottsdale Skin Boutique and Dermatology Pllc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-20
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
Tinted 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
34a52011-b781-75cf-e063-6394a90ae0f4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85331-203-15Tinted Sunscreen15 g in 1 PACKETCREAM152
85331-203-50Tinted Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85331-203TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a52011-b781-75cf-e063-6394a90ae0f4.zip
85331-203TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a632f5-4458-e335-e063-6394a90a9bcb.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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B Solutions SunscreenCOCONUT PINEAPPLE SCENTED SPF 50 STICKH.E.B29aef42c-f617-4c56-a166-8e1f0d6dbfd02021-07-09WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS58465981-e84c-4eaf-b7d5-fad1666f63fc2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 BambooOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASb2259b27-e1a5-482c-8916-356c1ee9774a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply BronzeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS199dde64-1dd3-4eb6-baef-261c97162f792021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 CremeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS753c34f2-3cb8-4df7-9aeb-ea926fb0279a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 DuneOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS745dd675-86ee-4acc-8333-4870e0a57c752021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 LatteOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASe66734e4-34e7-4674-bb98-bdca931a176d2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SandOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASbf78f7a7-93ca-425e-8571-175da6798e8e2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SepiaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS418cdd4a-23f7-4181-b734-5ab7456494a22021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ToffeeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS50138c51-f424-4b07-b3eb-c0d31d8ecf162021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 CameoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS01a861b9-0ab6-4c4c-a407-428a64509a1c2021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 BirchOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd5431d62-fded-4cdc-81a1-5b5e3eb928732021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 TawnyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS52c3378f-6b99-42fa-900e-8a693864c6152021-06-29WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenFACE SPF 70 LOTIONH.E.B73b49068-953b-496d-8ea9-404df7e790892021-01-19WarningsExact identifier
application number: M020
Think Every Day Face Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCafed91dd-8544-4b4b-e053-2995a90a2d162020-09-22WarningsExact identifier
application number: M020
THINKSPORT Kids sunscreen SPF 50ZINC OXIDEthinkOperations,LLC8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d2020-09-08WarningsExact identifier
application number: M020
THINKBABY Baby Sunscreen SPF 50ZINC OXIDEthinkOperations,LLC820317d2-1803-4949-bddf-09521a5d17502020-09-08WarningsExact identifier
application number: M020
THINKSPORT sunscreen SPF 50ZINC OXIDEthinkOperations,LLC6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea2020-08-03WarningsExact identifier
application number: M020
ESSENTIALS Face and Body SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsdfc44a01-e8fd-43fc-b3cd-5cac17e4a5a32020-04-02WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 18ZINC OXIDEthinkOperations,LLC9cd5010c-0b23-2888-e053-2995a90adb722020-01-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85331-203-158533102031515 g in 1 PACKET (85331-203-15) 15 g2022-07-28YesNoCurrent
85331-203-508533102035053 g in 1 BOTTLE, PUMP (85331-203-50) 53 g2022-07-20NoNoCurrent