FDA.reportPublic FDA data

Tinted Moisturizer SPF 46 Universal Tint

Product NDC
83286-009
Requested package NDC
83286-009-01
11-digit product format
832860009
Labeler code
83286
Product ID
83286-009_edd8e7d3-8a73-472d-b73f-c2433d7e8b09
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide, Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-08
Substance
ZINC OXIDE; OCTINOXATE
Active strength
12; 7.5 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Moisturizer SPF 46 Universal Tint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100mL
OCTINOXATE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5304b568-f891-4094-9182-363ae7bcfbe4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-009-01Tinted Moisturizer SPF 46 Universal Tint50 mL in 1 BOTTLECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83286-009TINTED MOISTURIZER SPF 46 UNIVERSAL TINT (ZINC OXIDE, OCTINOXATE) CREAM [DRMTLGY, LLC]1Current NDC, 1 package rows20250427_5304b568-f891-4094-9182-363ae7bcfbe4.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 128 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Mineral ProtectionZINC OXIDECharisma Skin352dc69b-86d0-aa15-e063-6294a90a5e4c2025-12-12Exact identifier
application number: M020
Ultra Sheer SunscreenZINC OXIDESKINBAR MD LLC35810a90-e2ca-b80b-e063-6294a90a14f02025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC3532102c-8ded-1e78-e063-6294a90ae2242025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC35330a82-dc6b-49af-e063-6394a90af9ea2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC353257db-6c30-4a03-e063-6294a90ae45d2025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC35334c75-b3fd-37fa-e063-6294a90ab3b02025-12-12Exact identifier
application number: M020
Age Defying SunscreenZINC OXIDEGINAMARIE Products35835565-f10b-e8e7-e063-6394a90ab2d32025-12-12Exact identifier
application number: M020
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
application number: M020
Age Defying SunscreenZINC OXIDEGINAMARIE Products35837cf7-91e5-f9ec-e063-6394a90aa91e2025-12-12Exact identifier
application number: M020
Mineral Sunscreen Face plus BodyZINC OXIDEKS Esthetics, LLC390a4d8d-b47f-0d9a-e063-6394a90a9b532025-12-12Exact identifier
application number: M020
Mineral Sunscreen Tinted Zinc OxideZINC OXIDEKS Esthetics, LLC3909e657-97a5-dd3c-e063-6394a90a10eb2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS366149e2-b03c-e798-e063-6394a90a6a1d2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS3661251d-b907-8df6-e063-6294a90a1c732025-12-12Exact identifier
application number: M020
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-009-018328600090150 mL in 1 BOTTLE (83286-009-01) 50 ml2025-04-08NoNoCurrent