Fade Cream Hydroquinone Skin Bleaching Agent Normal Skin

Hydroquinone Skin Bleaching Agent Normal Skin by

Drug Labeling and Warnings

Hydroquinone Skin Bleaching Agent Normal Skin by is a Otc medication manufactured, distributed, or labeled by Ambi Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROQUINONE SKIN BLEACHING AGENT NORMAL SKIN- hydroquinone, octinoxate cream 
Ambi Enterprises LLC

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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Fade Cream Hydroquinone Skin Bleaching Agent Normal Skin

Drug Facts

Active ingredients

Hydroquinone 2%

Octinoxate 2%

Purpose

Skin bleaching agent

Sunscreen

Uses

• for the gradual fading of dark (brownish) discolorations in the skin such as freckles, age and liver spots, pigment in the skin that may occur in pregnancy or from the use of oral contraceptives 
• contains a sunscreen to help prevent darkening from reoccurring

Warnings

For external use only

When using this product

avoid contact with eyes
some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

do not use

• on children under 12 years of age unless directed by a doctor 
• this product is not for use in the prevention of sunburn

Keep out of reach of children.

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

Directions

• adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
• children under 12 years of age: do not use unless directed by doctor 
• sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from reoccurring

Other information

for expiration date, see bottom of carton
store at room temperature

Inactive ingredients

water, glycerin, isopropyl myristate, stearic acid, cyclopentasiloxane, cetyl alcohol, betaine, hydoxyethyl urea, glycerl stearate, PEG-100 stearate, potassium cetyl phosphate, dimethicone crosspolymer, sodium metabisulfite, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, fragrance, tocopheryl acetate, methylparaben, disodium EDTA, lactic acid, propylparaben, ethylparaben, PEG-16 soy sterol, sodium ascorbyl phosphate, butylene glycol, glycine soja (soybean) protein

Questions or comments?

1-800-946-6354

Package Labeling:

HYDROQUINONE SKIN BLEACHING AGENT NORMAL SKIN 
hydroquinone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73453-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
BETAINE (UNII: 3SCV180C9W)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LACTIC ACID (UNII: 33X04XA5AT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ETHYLPARABEN (UNII: 14255EXE39)
PEG-16 SOY STEROL (UNII: 9J0FEN30IT)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SOYBEAN (UNII: L7HT8F1ZOD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73453-002-01	1 in 1 CARTON	08/24/2017	09/15/2022
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	08/24/2017	09/15/2022

Labeler - Ambi Enterprises LLC (117015229)

Revised: 9/2022

Document Id: e8cf8915-6d9d-5647-e053-2a95a90a2767

34390-5

Set id: bff54d15-c3e8-323f-e053-2a95a90aec65

Version: 3

Effective Time: 20220916