FDA.reportPublic FDA data

Sheglam Dew and Done Skin Tint with SPF 20 Caramel

Manufacturer
EVER FAME PTE. LTD.
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:44

Label at a glance#

ProductSheglam Dew and Done Skin Tint with SPF 20 Caramel
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating  children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.625%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating 
  • children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Dimethicone, Caprylyl Methicone, C9-12 Alkane, Butylene Glycol, Butyloctyl Salicylate, Dimethicone/PEG-10/15 Crosspolymer, Trimethylsiloxysilicate, Jojoba Seed Oil, Oryzanol, Isononyl Isononanoate, Magnesium Sulfate, 1,2-Hexanediol, PEG-10 Dimethicone, Hydroxyacetophenone, Triethoxycaprylylsilane, Sodium Hyaluronate, Dipropylene Glycol, Sodium Citrate, Gotu Kola Leaf Extract, Bisabolol, Tocopherol, Snow Lotus Extract, Xylitylglucoside, Anhydroxylitol, Xylitol, Ethylhexylglycerin, Ginger Root Extract, Titanium Dioxide Color, Iron Oxides Color.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label Caramel.jpgOuter Label Caramel.jpgInner Label Caramel.jpgInner Label Caramel.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
85068-007-01Sheglam Dew and Done Skin Tint with SPF 20 Caramel1 in 1 CARTONCREAM11
85068-007-01Sheglam Dew and Done Skin Tint with SPF 20 Caramel30 mL in 1 TUBECREAM301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85068-00785068-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
C9-12 ALKANE7J5R5W72QMIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
JOJOBA OIL724GKU717MIACT
ORYZANOLSST9XCL51MIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
MAGNESIUM SULFATEDE08037SABIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM HYALURONATEYSE9PPT4THIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE1Q73Q2JULRIACT
BISABOLOL24WE03BX2TIACT
TOCOPHEROLR0ZB2556P8IACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
ANHYDROXYLITOL8XWR7NN42FIACT
XYLITOLVCQ006KQ1EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GINGERC5529G5JPQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 CaramelZINC OXIDEEVER FAME PTE. LTD.2abc2ce2-bf4d-4efd-e063-6294a90ae9882025-01-02WarningsExact identifier
ndc (package): 85068-007-01
ndc (product): 85068-007
ndc11 (package): 85068000701
spl id: 2abc8a40-b891-5177-e063-6394a90a70de
spl set id: 2abc2ce2-bf4d-4efd-e063-6294a90ae988