Label: CLOVE HILL ACNE SAFE MINERAL SUNSCREEN SPF 40- zinc oxide cream
- NDC Code(s): 82746-205-04
- Packager: Clove Hill LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 22, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
-
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:
- DIRECTIONS:
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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 10:00 a.m.-2:00 p.m.
- Wear long-sleeved snirts, pants, hats, and sunglasses
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INACTIVE INGREDIENTS:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 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:
- Principal Display Panel – 115 g Bottle Label
-
INGREDIENTS AND APPEARANCE
CLOVE HILL ACNE SAFE MINERAL SUNSCREEN SPF 40
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82746-205 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 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) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82746-205-04 115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/01/2022 Labeler - Clove Hill LLC (071183319) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(82746-205) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(82746-205) , PACK(82746-205)
