SHUNLY ZN20 TINTED LIGHT MOISTURIZER- zinc oxide cream 
Shunly Skin Care LLC

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DRUG FACTS

ACTIVE INGREDIENTS:

Zinc Oxide 20%

PURPOSE:

Sunscreen

USES:

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.

WARNINGS:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. 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.

DIRECTIONS:

INACTIVE INGREDIENTS:

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl- PEG/PPG 10/1 Dimethicone, Cyclohexasiloxa ne. Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone /Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Iron Oxides, Hydrogren Dimethicone, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

OTHER INFORMATION:

FREE FROM: Chemical Sunscreens, Oils, PABA, Parabens, Fragrances

Manufactured for: Shunly Skin Care LLC

Meridian, ID 83646

www.shunlyskincare.com

Principal Display Panel – 60 g Bottle Label

shunly®

A BOTTLE
FULL OF SKINCARE

Zn20+ Tinted

SPF40 Light
Moisturizer

Broad Spectrum UV Defense

FUSION FORMULA® with
Zinc Oxide 20% / C / E

Water Resistant (40 mins)

NET.WT. 2.1 oz |60 g

Principal Display Panel – 60 g Bottle Label
SHUNLY ZN20 TINTED LIGHT MOISTURIZER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81381-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE 100 (UNII: RO266O364U)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81381-204-6060 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2022
Labeler - Shunly Skin Care LLC (040374013)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(81381-204)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81381-204) , PACK(81381-204)

Revised: 1/2024
Document Id: 595f8d8d-8c1a-4253-ac1e-dd36e2623b58
Set id: c046eef3-c2d7-42e6-a5ad-98e513fdb4e1
Version: 2
Effective Time: 20240117
 
Shunly Skin Care LLC