FDA.reportPublic FDA data

Sheglam Dew and Done Skin Tint with SPF 20 Truffle

Product NDC
85068-032
11-digit product format
850680032
Labeler code
85068
Product ID
85068-032_2acf75d2-8ad5-1bd3-e063-6294a90ac0be
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
EVER FAME PTE. LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-30
Substance
ZINC OXIDE
Active strength
146.25 mg/mL
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
Sheglam Dew and Done Skin Tint with SPF 20 Truffle
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE146.25 mg/mL

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
2acf4b3b-e830-d512-e063-6294a90a3fefAvailable 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85068-032-01Sheglam Dew and Done Skin Tint with SPF 20 Truffle1 in 1 CARTONCREAM11
85068-032-01Sheglam Dew and Done Skin Tint with SPF 20 Truffle30 mL in 1 TUBECREAM301

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 227 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUSH ON BLOCK SPF 50 KIDS MINERALZINC OXIDESPF Ventures, LLC2f17b5fe-44da-964b-e063-6394a90ae6992025-02-26WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
application number: M020
Rida Hair Research InstituteAVOBENZONE,OCTISALATE,OCTOCRYLENERida LLCece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 70 Peach BlossomAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed217698-f552-677e-e053-2995a90acb0a2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Tropical CoconutAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed0f8249-aba8-b67c-e053-2a95a90af7eb2025-02-25WarningsExact identifier
application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40ZINC OXIDE, OCTINOXATEPrivate Label Skin Caref176c1b1-f539-417f-98b5-69d99365f2f22025-02-25WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f2780cb5-063c-10d3-e053-2995a90a85762025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2ee9b3dc-91cd-1af9-e063-6394a90a78e12025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2edc79f8-aac5-15eb-e063-6394a90a97362025-02-23WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-COCTINOXATE, ZINC OXIDEBEL STAR S Adc25651b-0e30-c325-e053-2995a90a809e2025-02-21WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-COCTINOXATE, ZINC OXIDEBEL STAR S Adc129cd6-a173-d2b3-e053-2a95a90aa04e2025-02-21WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 TintedAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeec6e7c8-17fe-f34b-e053-2995a90a78a02025-02-20WarningsExact identifier
application number: M020
DropsAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.1319d6ea-a580-79c5-e063-6394a90a4dca2025-02-20WarningsExact identifier
application number: M020
Vacation SPF 50 Super Spritz Face MistAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.f67fbe98-93ce-2882-e053-2a95a90ab7132025-02-20WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
application number: M020
Mineral SPF 30 Brush-On Sun DefenseZINC OXIDEMineral Fusion29733dba-8824-461e-be44-335d6fe50d602025-02-19WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Pina ColadaAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCedc59de7-c817-1a59-e053-2995a90a34082025-02-17WarningsExact identifier
application number: M020
Liplux SPF 30 Lip BalmCLASSICCOOLA LLCb47b5f3a-43f3-ae7a-e053-2995a90ae16d2025-02-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85068-032-01850680032011 TUBE in 1 CARTON (85068-032-01) / 30 mL in 1 TUBE1 tube2025-05-30NoNoCurrent