GZE TINTED SUNSCREEN- zinc oxide 3% cream

GZE Tinted Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

GZE Tinted Sunscreen

ACTIVE INGREDIENT

Zinc Oxide 3%

PURPOSE

HELPS PREVENT UV DAMAGE 8 SIGNS OF AGING

INDICATIONS & USAGE

SILKY LOTION MATTIFIES WITH A SHEER, NATURAL TINT FOR ALL SKIN TONES

IHELPS PREVENTUV DAMAGE& SIGNS OF AGING

WARNINGS

For exteral use only, if it gets into eves accidentally, rinse with plenty of water, seek medical attention immediately if you feel unwell.Keep out of reach of children.

DO NOT USE

WHEN USING

Super-Light Daily Wrinkle Defense

INSTANTLY OBTAlN seemingly flawless, glowingskin. Perfect for that no-make up lOOK.FORMULATED AS AN ALLIN ONESUNSCREEN ANDFOUNDATiON that provides sheer color coverage minimizes the appearance of fine lines andwrinkles, and blendsnaturaly to match every sKintone.LIGHTWEIGHT AND NON-GREASY FORMULA thatimproves your skin's hydration and texture overtime.

STOP USE

For external use only, ifit gets into eyes accidentally, rinse with plenty of water, seek medical attention immediately if you feel unwell.Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Squeeze out an appropriate amount of sunscreen and spread evenly on skin

STORAGE AND HANDLING

Store in a cool dry place

INACTIVE INGREDIENT

Water

Polydimethylsiloxane

Peg Ppg-1818polydimethylsiloxane

DIMETHICONE

PEG-12 DIMETHICONE

Resveratrol

SOY ISOFLAVONES

Epicatechin

Tocopherol Acetate

ASCORBYL TETRAISOPALMITATE

Adenosine

LAUROYL LYSINE

Red Myrrh Alcohol

TRIHYDROXYSTEARIN

Barkextract Of Salixalba

Pomegranate Extract

Haematococcus Pluvialis Extract

Hydrolyzedcorn Starch

Polysorbate-80

Silica Triethoxy Octylsilane

C12-15 Alcohol Benzoate

Triisostearic Acidisopropyl Titanium Salt

Octanol

Hexanediol

Sodium Argon

Ethyl Hexyl Glycerol

2-Phenoxyethanol

lron Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE TINTED SUNSCREEN 
zinc oxide 3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAUROYL LYSINE (UNII: 113171Q70B)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
EPICATECHIN (UNII: 34PHS7TU43)
HEXANEDIOL (UNII: ZIA319275I)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LEVOMENOL (UNII: 24WE03BX2T)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
SALIX ALBA BARK (UNII: 205MXS71H7)
RESVERATROL (UNII: Q369O8926L)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POMEGRANATE (UNII: 56687D1Z4D)
MALTOTETRAOSE (UNII: BO88JLT87R)
WATER (UNII: 059QF0KO0R)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SOY ISOFLAVONES (UNII: 71B37NR06D)
ADENOSINE (UNII: K72T3FS567)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-100-01	40 mL in 1 TUBE; Type 0: Not a Combination Product	07/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/07/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co.,Ltd.		712647107	manufacture(83566-100)