FDA.reportPublic FDA data

Sheglam Dew and Done Skin Tint with SPF 20 Mocha

Product NDC
85068-021
11-digit product format
850680021
Labeler code
85068
Product ID
85068-021_2abd75d7-2c22-29f9-e063-6394a90aa007
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 Mocha
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
2abd75c3-554f-d428-e063-6294a90ae77dAvailable 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
85068-021-01Sheglam Dew and Done Skin Tint with SPF 20 Mocha30 mL in 1 TUBECREAM301
85068-021-01Sheglam Dew and Done Skin Tint with SPF 20 Mocha1 in 1 CARTONCREAM11

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 230 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.02a72c6d-da42-14b2-e063-6394a90af5cb2025-02-06WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow SerumZINC OXIDE 20%EMMA LEWISHAM US, INC.2b097709-913f-d906-e063-6394a90a04462025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
application number: M020
doTERRA SunZINC OXIDEdoTERRA International, LLCdd308fef-e312-4ced-e053-2995a90a76fd2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 15gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDb686ef63-7eee-4a4d-a559-417d8b09cc4f2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 22gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDd3c422f6-a83d-48fc-94fc-2749666426c82025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2d6a6fed-a26e-e3a6-e063-6394a90ae2c72025-02-05WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral MoistureZINC OXIDESPF Ventures, LLC2d4b8c92-b932-89a7-e063-6394a90a621d2025-02-04WarningsExact identifier
application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY30ca8f9d-b6a5-4af0-9d7b-487212e40e632025-02-03WarningsExact identifier
application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY3057f8ad-5850-49a0-b44d-3a1da84126e32025-02-03WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 ALMOND WD1HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.4ebd7db8-7e6c-46ed-9d0c-6f9f81ea65fe2025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e4466bcb-278a-44bb-a87b-479c14037e762025-02-03WarningsExact identifier
application number: M020
JJAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 BISQUE MDN4HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.282c72a8-bcfa-417f-a79d-9dcf688588332025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.15eae33b-e8f5-4334-8bf9-fa02ed6ff46d2025-02-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85068-021-01850680021011 TUBE in 1 CARTON (85068-021-01) / 30 mL in 1 TUBE1 tube2025-05-30NoNoCurrent