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
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 Mineral 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
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 156 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4495a302-51b9-3bf2-e063-6294a90a7e4f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa1349-e3f1-9b80-e063-6294a90a0fbd2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aaa3c8-ccc4-ae93-e063-6394a90aedc52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba591-04da-fe09-e063-6394a90a912a2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba6d7-7989-0637-e063-6394a90a6c8f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abca13-8ba9-8925-e063-6294a90accb52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abdfe1-ea6b-a158-e063-6294a90a3eb82025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca1d5-6e0a-def3-e063-6294a90aca262025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca181-2a90-20a6-e063-6394a90aff472025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa529b-2077-3660-e063-6394a90aa4052025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ad65f0-ec1d-1638-e063-6294a90a22442025-11-28WarningsExact identifier
application number: M020
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
application number: M020
OCEAURA Glitter SunscreenTITANIUM DIOXIDEGuangzhou Oceaura Biotechnology Co., Ltd.44b47284-57cd-2e61-e063-6394a90a50722025-11-28WarningsExact identifier
application number: M020
OUHOE Moisturizing And Translucent SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.34e8e4a6-2782-9a3d-e063-6394a90a84c22025-11-27WarningsExact identifier
application number: M020
OUHOE Protection SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4272dcef-eda5-1013-e063-6294a90adf382025-11-27WarningsExact identifier
application number: M020
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact 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