BRIGHTENING GREAM- 3-0-ethyl ascorbic acid lotion

Brightening Gream by

Drug Labeling and Warnings

Brightening Gream by is a Otc medication manufactured, distributed, or labeled by Shengnan (Guangzhou) Cosmetics Co.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

3-o-ethyl ascorbic acid 1%

Purpose

Whitening Cream

WARNINGS

For external use only, When using this product:Avoid direct contact with eyes, Some users ofthisproduct and experience a mild skin irritation. Ifskinirritation becomes severe, stop use and consult adoctor, Do not use on children under 12 years ofage unless directed by a doctor.

Stop use and ask a doctor if

rash occurs

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

INACTIVE INGREDIENT

water 74.75%
glycerin 8%
paraffinum liquidum 8%

titanium dioxide 2%

cetearyl alcohol 2.5%

carbomer 0.2%

xanthan gum 0.5%

phyllostachys bambusoides extract 1%

lycium barbarum fruit extract 0.3%

sophora flavescens root extract 0.3%

Pyracantha fortuneana root extract 0.3%

tocopherol 0.5%

citruslimon (lemon)extract 0.2%

caprylhydroxamicacid 0.05%

phenoxyethanol 0.2%

methylparaben 0.2%

DOSAGE

Once a day, do not rinse with cold water within 2 hours after use.

INDICATIONS & USAGE

Helps reduce pigmentation on the skin, making the skin tone more even.Whitening cream is suitable for facial skin and can be applied evenly or topically throughout the entire face.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRIGHTENING GREAM 
3-0-ethyl ascorbic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) (3-O-ETHYL ASCORBIC ACID - UNII:6MW60CB71P)	3-O-ETHYL ASCORBIC ACID	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER 980 (UNII: 4Q93RCW27E)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-005-01	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/02/2024

Labeler - Shengnan (Guangzhou) Cosmetics Co.,LTD (541200425)

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co.,LTD		541200425	manufacture(84019-005)