SKIN APEEL PURE PROTECT SPF 40 BROAD SPECTRUM- zinc oxide cream 
Skin Apeel, Inc.

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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 skin aging caused by the sun.

DIRECTIONS:

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 40 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

• Children under 6 months: Ask a doctor

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 am-2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS: C- Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, 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: • Protect this product from excessive heat and direct 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.

Reference Value

Keep out of the reach of children.

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

Apply liberally 15 minutes befor sun exposure.

#205 Skin Apeel Day SpaPrincipal Display Panel – 113 g Bottle Label

skin apeel

organic results • cruelty free

Pure Protect

SPF 40

Broad Spectrum

Water Resistant

(40 Mins)

Non-tinted . zinc oxide
antioxidants c + e

Net Wt. 4 oz/ 113 g

Graphic-Untitled

SKIN APEEL PURE PROTECT SPF 40 BROAD SPECTRUM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83628-205
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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE 100 (UNII: RO266O364U)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83628-205-40113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/20/2024
Labeler - Skin Apeel, Inc. (840716328)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372analysis(83628-205)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000manufacture(83628-205) , pack(83628-205)

Revised: 5/2024
Document Id: 1bbdb94a-5844-b450-e063-6394a90a38b0
Set id: 18e78c7f-1523-a4f4-e063-6394a90aed97
Version: 3
Effective Time: 20240520
 
Skin Apeel, Inc.