PREVENTION PLUS DAILY HYDRATING MOISTURIZER SPF 30- zinc oxide cream 
Allure Labs Inc

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:

Zinc Oxide 21.0%

Purpose: Sunscreen

Uses:

Warning: For external use only.

Do not use: on damaged or broken skin.

When using this products:

Stop use and ask a doctor if :rash occurs.

Keep out of reach of children:

Directions For Sunscreen Use:

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients: AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, GLYCERIN, BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, BUTYROSPERMUM PARKII NUT EXTRACT, STYRENE/ACRYLATES COPOLYMER, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, CYCLOHEXASILOXANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYSILICONE-31, SORBITAN STEARATE, CETYL ALCOHOL, PHENOXYETHANOL, HEA/SODIUM ACRYOLYDIMETHYLTAURATE/STEARETH-20 METHACRYLATE COPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, HYDROLYZED JOJOBA ESTERS, LIMONENE, CAPRYLYL GLYCOL, ALLANTOIN, C13-14 ISOPARAFFIN, LAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, XANTHAN GUM, BISABOLOL, POLYSORBATE 80, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, DECYL GLUCOSIDE, ERYTHRITOL, SODIUM HYALURONATE, BIOSACCHARIDE GUM-1, VANILLA PLANIFOLIA FRUIT EXTRACT, GLUCOSE, HYDROLYZED PEA PROTEIN, PYRUVIC ACID, SODIUM CHLORIDE, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, POTASSIUM SORBATE, SODIUM BENZOATE, HOMARINE HCL, SODIUM SUCCINATE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

Manufactured for IMAGE Skincare, Lantana, FL 33462 USA

Manufactured in USA from globally sourced ingredients and components

www.ImageSkincare.com

Prevention Plus Daily Hydrating Moisturizer SPF 30

Call 800-796-7546

PREVENTION PLUS DAILY HYDRATING MOISTURIZER SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE210 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SHEANUT (UNII: 84H6HBP32L)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
STEARETH-20 METHACRYLATE (UNII: A268NZ57NB)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MANDARIN OIL (UNII: NJO720F72R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LEVOMENOL (UNII: 24WE03BX2T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ERYTHRITOL (UNII: RA96B954X6)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
VANILLA (UNII: Q74T35078H)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
PEA PROTEIN (UNII: 7Q50F46595)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
ANACYSTIS NIDULANS (UNII: UV4FTL6UAW)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4183-1170 g in 1 TUBE; Type 0: Not a Combination Product12/11/2019
2NDC:62742-4183-31 in 1 CARTON12/11/2019
2NDC:62742-4183-291 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:62742-4183-47 g in 1 TUBE; Type 0: Not a Combination Product12/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/11/2019
Labeler - Allure Labs Inc (926831603)

Revised: 12/2019
Document Id: 22ef5151-40ab-40d0-9f80-2f79c9166b15
Set id: 36db53e1-1e42-48ae-a3c8-aff59e4141a2
Version: 1
Effective Time: 20191211
 
Allure Labs Inc