Label: SKIN APEEL PURE PROTECT SPF 40 BROAD SPECTRUM- zinc oxide cream
- NDC Code(s): 83628-205-40
- Packager: Skin Apeel, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 20, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
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
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INACTIVE INGREDIENT
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 SAFETY INFORMATION
- WARNINGS
- REFERENCES
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN APEEL PURE PROTECT SPF 40 BROAD SPECTRUM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83628-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83628-205-40 113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/20/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/20/2024 Labeler - Skin Apeel, Inc. (840716328) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(83628-205) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 manufacture(83628-205) , pack(83628-205)
