PREBIOTIX SPF 45 GLOW- zinc oxide lotion

PREBIOTIX SPF 45 Glow by

Drug Labeling and Warnings

PREBIOTIX SPF 45 Glow by is a Otc medication manufactured, distributed, or labeled by Juice Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Zinc Oxide 22%
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.

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
- Due to the nature of mineral formulations shake and knead the tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure. May be used over moisturizer or alone.
- 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 a.m.–2 p.m.
  - wear long-sleeved shirts, pants, hats, and sunglasses
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor.
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

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

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

INGREDIENTS AND APPEARANCE

PREBIOTIX SPF 45 GLOW
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55165-0301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	22 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55165-0301-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/19/2023

Labeler - Juice Beauty (263151582)