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

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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DRUG FACTS

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

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 not finalpart35208/14/2023
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: 8/2023
Document Id: f31d542f-d388-4a59-97d6-ff0d8bf5b545
Set id: a64e373b-b3f6-4024-b5f5-253783485cd6
Version: 1
Effective Time: 20230814
 
Shunly Skin Care