SHUNLY NATURAL COVER SPF50- titanium dioxide, zinc oxide cream 
Shunly Skin Care

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ACTIVE INGREDIENTS:

Titanium Dioxide 10%

Zinc Oxide 3%

PURPOSE:

Sunscreen

Sunscreen

USES:

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin 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 the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

INACTIVE INGREDIENTS:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

OTHER INFORMATION:

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

Manufactured for: Shunly Skin Care LLC

Meridian, ID 83642

www.shunlyskincare.com

Keep out of the reach of children.

Principal Display Panel – 53 g Bottle Label

shunly®

A BOTTLE
FULL OF SKINCARE

Natural Cover

SPF50

Broad Spectrum UV Defense

Satin Finish With Hydrate & Antioxidants

FUSION FORMULA®with
Physical Filters / C / E

Water Resistant (40 minutes)

NET. WT. 1.8 oz | 53 g

Principal Display Panel – 53 g Bottle Label
SHUNLY NATURAL COVER SPF50 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81381-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISODODECANE (UNII: A8289P68Y2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81381-258-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/14/2023
Labeler - Shunly Skin Care (040374013)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372analysis(81381-258)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000manufacture(81381-258) , pack(81381-258)

Revised: 11/2024
Document Id: 26aaf15d-33b8-5aa1-e063-6394a90aab58
Set id: a64e373b-b3f6-4024-b5f5-253783485cd6
Version: 2
Effective Time: 20241111
 
Shunly Skin Care