FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85513-203
11-digit product format
855130203
Labeler code
85513
Product ID
85513-203_458a10b1-70d3-5984-e063-6294a90a6c8b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
THE AESTHETICS ACADEMY, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-22
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 Mineral 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
364b9560-f7a1-ed8f-e063-6294a90a2c41Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85513-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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 287 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MARIO BADESCU ALOE SPFAVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC189a7421-8598-44fc-9506-13c6dff8989c2024-09-10WarningsExact identifier
application number: M020
Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC17a7492b-5243-48c4-b808-5e9899db75302024-09-08WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
application number: M020
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.20e122e2-09ad-63ad-e063-6294a90a83fc2024-08-30WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
application number: M020
OS-01 Body SPF 30ZINC OXIDEONESKIN, INC20eb4d43-cf4d-dde3-e063-6394a90a6cb82024-08-30WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
application number: M020
JACKET SPF-50 Broad Spectrum SunscreenZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSfcc45edd-098c-4f27-9712-0db36cfa0fdc2024-08-29WarningsExact identifier
application number: M020
LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUIDAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAX HUBER RESEARCH LAB INCe06bb578-475c-4169-ac09-cefb6a37d3922024-08-29WarningsExact identifier
application number: M020
dr. brandt SUN SHIELD SPF 50ZINC OXIDEDr. Brandt6f8af59b-d423-4250-8ddc-061fea886e3e2024-08-28WarningsExact identifier
application number: M020
dAlba Vegan Tone-Up SunscreenHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDEADMTMAX LLC20adebef-2841-a5c2-e063-6394a90ab0632024-08-27WarningsExact identifier
application number: M020
doTERRA sun Lip Balm Mineral SunscreenMINERAL SUNSCREENdoTERRA International, LLC20afcd34-efa6-30a7-e063-6394a90ab5172024-08-27WarningsExact identifier
application number: M020
SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.2bb9798f-36a0-4d03-a316-8b746a9283d82024-08-26WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.202e99ef-330e-ad94-e063-6294a90a2d2a2024-08-21WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a7dc68-6384-3783-e063-6394a90ac8392024-08-19WarningsExact identifier
application number: M020
Wegmans Sport and Kids Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf424da9c-5218-1d8d-e053-2a95a90a29fb2024-08-19WarningsExact identifier
application number: M020
Topcare Everyday Sport Continuous Broad Spectrum SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLC2010b724-e681-f544-e063-6294a90a21402024-08-19WarningsExact identifier
application number: M020
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85513-203-508551302035053 g in 1 BOTTLE, PUMP (85513-203-50) 53 g2023-12-22NoNoCurrent