PREBIOTIX SPF 45 GLOW- zinc oxide lotion 
Juice Beauty

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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PREBIOTIX® SPF 45 Glow

Drug Facts

Active Ingredient

Zinc Oxide 22%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Aloe barbadensis leaf juice1, butyloctyl salicylate, caprylic/capric triglyceride2, polyester-8, glycerin1, cetearyl alcohol2, glyceryl stearate2, glycolipids2, squalane2, sorbitan sesquioleate2, isoamyl laurate2, vitis vinifera (grape) seed oil1, simmondsia chinensis (jojoba) seed oil1, hyaluronic acid, coco-glucoside2, hydrolyzed jojoba esters2, tocopherol (Vitamin E)2, bisabolol2, ectoin2, hydrolyzed viola tricolor extract2, phyllanthus emblica fruit extract2, inulin2, glyceryl caprylate2, mica, iron oxides, caprylhydroxamic acid2, polyhydroxystearic acid, lysolecithin2, sclerotium gum2, xanthan gum2, pullulan2, sodium stearoyl glutamate, sodium riboflavin phosphate, leuconostoc/radish root ferment filtrate2, maltodextrin2, titanium dioxide, silica, citric acid.


1
certified organic ingredient
2
plant-derived

Other Information

Questions?

Email customerservice@juicebeauty.com or visit www.juicebeauty.com

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

JUICE BEAUTY
PREBIOTIX®
SPF 45 Glow

Daily Multi-Tasking
Moisturizer

broad spectrum
SPF 45 sunscreen

50 mL / 1.7 fl oz
NPN 80122647

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PREBIOTIX SPF 45 GLOW 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide22 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS (UNII: PB22NX2CJL)  
SQUALANE (UNII: GW89575KF9)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
COCO GLUCOSIDE (UNII: ICS790225B)  
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LEVOMENOL (UNII: 24WE03BX2T)  
ECTOINE (UNII: 7GXZ3858RY)  
VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
INULIN (UNII: JOS53KRJ01)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS (UNII: 957E53WV42)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55165-0301-150 mL in 1 TUBE; Type 0: Not a Combination Product02/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/19/2023
Labeler - Juice Beauty (263151582)

Revised: 2/2023
Document Id: 985fd351-b912-4aa7-92b1-c0c1f30253f4
Set id: b9a46880-5df1-4baa-8ac5-d258b2002158
Version: 1
Effective Time: 20230213
 
Juice Beauty