FDA.reportPublic FDA data

Sheglam Dew and Done Skin Tint with SPF 20 Warm Vanilla

Product NDC
85068-034
11-digit product format
850680034
Labeler code
85068
Product ID
85068-034_2acfae2b-15bb-556a-e063-6294a90ab3f1
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 Warm Vanilla
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
2acf9020-c779-31c2-e063-6294a90a1ab5Available 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
85068-034-01Sheglam Dew and Done Skin Tint with SPF 20 Warm Vanilla1 in 1 CARTONCREAM11
85068-034-01Sheglam Dew and Done Skin Tint with SPF 20 Warm Vanilla30 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 210 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30ZINC OXIDEAndalou naturals9314e4fc-ba3e-480e-a005-b8928130ed702025-06-06WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac2025-06-05WarningsExact identifier
application number: M020
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d65cb2-c2e7-06d7-e063-6394a90a38222025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d747fb-b973-5611-e063-6394a90ac6612025-06-05WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
application number: M020
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
application number: M020
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-XAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences812caa99-1e1e-4ab8-9f9a-fb3384c684dd2025-06-05WarningsExact identifier
application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVBAVOBENZONE, OCTOCRYLENE, AND OCTISALATEMDSolarSciencesba918886-d277-487a-be3b-bbe3e24343ad2025-06-05WarningsExact identifier
application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow TintAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences3e392af6-1401-4a2f-9ba4-e43f0fd0fca12025-06-05WarningsExact identifier
application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted MoisturizerAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences51bd8962-e85a-4964-9337-2ded6b7d8ac82025-06-05WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB SunscreenAVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences0f23441c-2399-4a72-9f0a-420d25db78af2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36da165b-bc68-24ff-e063-6294a90a304f2025-06-05WarningsExact identifier
application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85068-034-01850680034011 TUBE in 1 CARTON (85068-034-01) / 30 mL in 1 TUBE1 tube2025-05-30NoNoCurrent