GZE SCALP HAIR MIST- octocrylene,homosalate spray

GZE Scalp Hair Mist by

Drug Labeling and Warnings

GZE Scalp Hair Mist by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octocrylene

14.3%

Homosalate

10%

Purpose

We have created a light, fast drying scalp spray that will not make your hair heavy or greasy to ensure a happy day in the sun.

Uses

Spray directly on hair and exposed scalp.Use15 minutes before sun exposure.

WARNINGS

For external use only.

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 help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

HELIANTHUS ANNUUS WHOLE
WATER
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
BUTYLOCTYL SALICYLATE
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)
LAMINARIA DIGITATA
GLYCERIN
CAPRYLICICAPRICILINOLEIC TRIGLYCERIDE
LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID

DOSAGE & ADMINISTRATION

Spray directly on hair and exposed scalp. Use 15 minutes before sun exposure.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE SCALP HAIR MIST 
octocrylene,homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	14.3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
WATER (UNII: 059QF0KO0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID (UNII: 9E3P882579)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-218-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/20/2023

Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co.,Ltd.		712647107	manufacture(83566-218)