Gilded Glam BB Cream DHA Face Bronzer Broad Spectrum SPF 10

Gilded Glam by

Drug Labeling and Warnings

Gilded Glam by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GILDED GLAM BROAD SPECTRUM SPF 10- avobenzone, octisalate, octocrylene lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gilded Glam BB Cream DHA Face Bronzer Broad Spectrum SPF 10

Active Ingredients

Avobenzone 2%, Octisalate 5%, Octocrylene 1.85%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

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

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

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

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

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Questions or comments?

Call toll free 1-855-548-4653

Gilded Glam BB Cream SPF 10

GILDED GLAM  BROAD SPECTRUM SPF 10
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	17.48 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.25 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	18.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
VANILLA (UNII: Q74T35078H)
LIME PEEL (UNII: 544EQK5Q0W)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
ENGLISH WALNUT (UNII: 1V3SHR7QB7)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
CARAMEL (UNII: T9D99G2B1R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE PEEL (UNII: TI9T76XD44)
ERYTHRULOSE, D- (UNII: 09058VOU0Z)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MANGO (UNII: I629I3NR86)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TANGERINE PEEL (UNII: JU3D414057)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	brown (Light Caramel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0303-3	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2018	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/30/2018	11/20/2020

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	manufacture(58443-0303) , label(58443-0303) , analysis(58443-0303) , pack(58443-0303)

Revised: 5/2022

Document Id: ded14236-497a-214a-e053-2a95a90a14bc

34390-5

Set id: b2329fed-93e1-87a2-e053-2995a90aede8

Version: 2

Effective Time: 20220512