FDA.reportPublic FDA data

Umbra Tinte Mineral Cream SPF 30

Product NDC
69455-167
11-digit product format
694550167
Labeler code
69455
Product ID
69455-167_47b965e1-6106-4d59-e063-6394a90a15f5
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Drunk Elephant, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-11
Substance
ZINC OXIDE
Active strength
12 g/60mL
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
Umbra Tinte Mineral Cream SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/60mL

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
6461d19a-16e7-43ac-943c-229fe2c6f76cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69455-167-10Umbra Tinte Mineral Cream SPF 301 in 1 BOXCREAM14
69455-167-10Umbra Tinte Mineral Cream SPF 3060 mL in 1 TUBECREAM604
69455-167-20Umbra Tinte Mineral Cream SPF 301 in 1 TUBECREAM14
69455-167-20Umbra Tinte Mineral Cream SPF 305 mL in 1 CARTONCREAM54
69455-167-30Umbra Tinte Mineral Cream SPF 302 mL in 1 PACKETCREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69455-167UMBRA TINTE MINERAL CREAM SPF 30 (ZINC OXIDE) CREAM [DRUNK ELEPHANT, LLC]3Current NDC, 5 package rows20250323_6461d19a-16e7-43ac-943c-229fe2c6f76c.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 14 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACHZINC OXIDECOSMAX USA, CORP564b63f2-701e-f5bd-e063-6394a90af7972026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTSZINC OXIDECOSMAX USA, CORP564b5ab3-0a7c-f663-e063-6394a90a0c3d2026-07-10WarningsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA564b8070-ee59-0c24-e063-6294a90ad9a92026-07-10WarningsExact identifier
application number: M020
COCO-EVE COCONUT MILK BODY SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564b80c2-16e0-fb5f-e063-6394a90a50d22026-07-10WarningsExact identifier
application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA564b9b1f-3d5b-4349-e063-6294a90a3b772026-07-10WarningsExact identifier
application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDECOSMAX USA564ba912-c44b-4940-e063-6294a90a28fa2026-07-10WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564bbb5f-4000-390d-e063-6294a90a408d2026-07-10WarningsExact identifier
application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30ZINC OXIDECOSMAX USA564bb5f9-5ac5-548b-e063-6394a90a84622026-07-10WarningsExact identifier
application number: M020
ILLUSION LUMINOUS GLOW FOUNDATIONAVOBENZONE, HOMOSALATE, AND OCTISALATEKingdom Animalia, LLC DBA Hourglass Cosmeticscf6a7e1a-7bca-439c-808a-80262f095f842026-07-10WarningsExact identifier
application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEThe Procter & Gamble Manufacturing Company30a063fa-e537-a2c1-e063-6394a90a6a832026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 SensitiveOCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb971e1-34f1-ee89-e063-6394a90a52a92026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb9de81-f05e-9697-e063-6394a90a69c52026-07-09WarningsExact identifier
application number: M020
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
application number: M020
Sunny C Sunscreen SPF 50SUNNY C SUNSCREENMIXIK, INC.4ed2a482-6c63-69f5-e063-6394a90ad3ee2026-07-08WarningsExact identifier
application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.24389324-19db-7eb5-e063-6394a90ad7fb2026-07-08WarningsExact identifier
application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONECOSMAX USA, CORPORATION562053d4-12bd-976e-e063-6394a90a59de2026-07-08WarningsExact identifier
application number: M020
Skin Medicinals SM Clear Broad Spectrum SPF 50ZINC OXIDE, OCTINOXATESKIN MEDICINALS LLC364e9bac-85c4-afbd-e063-6394a90aba822026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
application number: M020
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69455-167-10694550167101 TUBE in 1 BOX (69455-167-10) / 60 mL in 1 TUBE1 tube2024-06-11NoNoCurrent
69455-167-20694550167201 CARTON in 1 TUBE (69455-167-20) / 5 mL in 1 CARTON1 carton2024-06-11NoNoCurrent
69455-167-30694550167302 mL in 1 PACKET (69455-167-30) 2 ml2024-06-11NoNoCurrent