CLOVE HILL ACNE SAFE MINERAL SUNSCREEN SPF 40- zinc oxide cream 
Clove Hill LLC

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DRUG FACTS

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.

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:

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:

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:

Protect this product from excessive heat and direct sun

May stain some fabrics

Principal Display Panel – 115 g Bottle Label

CLOVE HILL

come home to clear skin

acne-safe
mineral sunscreen

spf 40 broad spectrum

water resistant (40 mins)

net wt. 4 oz /115 g

Principal Display Panel – 115 g Bottle Label
CLOVE HILL ACNE SAFE MINERAL SUNSCREEN SPF 40 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82746-205
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82746-205-04115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/2022
Labeler - Clove Hill LLC (071183319)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(82746-205)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(82746-205) , PACK(82746-205)

Revised: 1/2024
Document Id: 3f2d010f-9a36-40e6-9ac1-c1daa3a56a2c
Set id: a06e6393-13c5-48b9-909a-3bdf7d58cad3
Version: 2
Effective Time: 20240122
 
Clove Hill LLC