FDA.reportPublic FDA data

Tinted Sunscreen

Product NDC
85331-208
11-digit product format
853310208
Labeler code
85331
Product ID
85331-208_45af1972-d2cc-1b3f-e063-6394a90a88dd
Type
HUMAN OTC DRUG
Nonproprietary name
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
ZINC OXIDE
Active strength
160 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
Tinted Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
34a54441-c741-0c46-e063-6294a90a9be8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85331-208-15Tinted Sunscreen15 g in 1 PACKETCREAM152
85331-208-50Tinted Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85331-208TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a54441-c741-0c46-e063-6294a90a9be8.zip
85331-208TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a66140-0d36-005a-e063-6394a90a2a0b.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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85331-208-158533102081515 g in 1 PACKET (85331-208-15) 15 g2022-07-28YesNoCurrent
85331-208-508533102085053 g in 1 BOTTLE, PUMP (85331-208-50) 53 g2022-07-20NoNoCurrent