FDA.reportPublic FDA data

Gilded Glam BB Cream DHA Face Bronzer Broad Spectrum SPF 10

Manufacturer
Prime Enterprises Inc.
Effective date
2020-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:16

Label at a glance#

ProductGilded Glam Broad Spectrum SPF 10
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure for darker color results, use daily wash hands after application reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octisalate 5%, Octocrylene 1.85%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure

for darker color results, use daily

wash hands after application

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, Caramel, Ceteareth-20, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Aurantifolia (Lime) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Dihydroxyacetone, Dimethicone, Disodium EDTA, Erythrulose, Glyceryl Dilaurate, Isopropylphthalimide, Juglans Regia (Walnut) Seed Extract, Mangifera Indica (Mango) Fruit Extract, Methylisothiazolinone, Phenoxyethanol, Polyethylene, Propylene Glycol, Silica, Stearyl Alcohol, Tocopheryl Acetate, Trimethylsiloxysilicate, Vanilla Planifolia Fruit Extract, Water

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-548-4653

Gilded Glam BB Cream SPF 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-030358443-0303-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
VANILLAQ74T35078HIACT
LIME PEEL544EQK5Q0WIACT
CETYL ALCOHOL936JST6JCNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
OCTISALATE4X49Y0596WACTIB
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
ENGLISH WALNUT1V3SHR7QB7IACT
CITRUS MAXIMA FRUIT RIND5NX3G75CA6IACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
CARAMELT9D99G2B1RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ORANGE PEELTI9T76XD44IACT
ERYTHRULOSE, D-09058VOU0ZIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MANGOI629I3NR86IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
GLYCERYL DILAURATEMFL3ZIE8SKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TANGERINE PEELJU3D414057IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIHYDROXYACETONEO10DDW6JOOIACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
AVOBENZONEG63QQF2NOXACTIB

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
ded14236-497a-214a-e053-2a95a90a14bcb2329fed-93e1-87a2-e053-2995a90aede82022-05-12WarningsExact identifier
spl set id: b2329fed-93e1-87a2-e053-2995a90aede8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.