Prebiotix®

Prebiotix®
SPL v2
SPL
SPL Set ID b9a46880-5df1-4baa-8ac5-d258b2002158
Route
TOPICAL
Published
Effective Date 2024-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Medium-chain Triglycerides Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Glycerin Cetostearyl Alcohol Glyceryl Stearate Se Pseudomonas Glucose Fermentation Rhamnolipids Squalane Sorbitan Sesquioleate Isoamyl Laurate Grape Seed Oil Jojoba Oil Hyaluronic Acid Coco-glucoside Potassium Hydrolyzed Jojoba Esters Tocopherol Levomenol Ectoine Viola Tricolor Whole Phyllanthus Emblica Fruit Inulin Glyceryl Monocaprylate Mica Ferric Oxide Yellow Caprylhydroxamic Acid Polyhydroxystearic Acid (2300 Mw) Lysophosphatidylcholine, Soybean Betasizofiran Xanthan Gum Pullulan Sodium Stearoyl Glutamate Riboflavin 5'-phosphate Sodium Anhydrous Leuconostoc/radish Root Ferment Filtrate Maltodextrin Titanium Dioxide Silicon Dioxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-19

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only

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.
Questions?

Email [email protected] or visit www.juicebeauty.com

Active Ingredient

Zinc Oxide 22%

Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

Aloe barbadensis leaf juice

certified organic ingredient
, butyloctyl salicylate, caprylic/capric triglyceride
plant-derived
, polyester-8, glycerin
, cetearyl alcohol
, glyceryl stearate
, glycolipids
, squalane
, sorbitan sesquioleate
, isoamyl laurate
, vitis vinifera (grape) seed oil
, simmondsia chinensis (jojoba) seed oil
, hyaluronic acid, coco-glucoside
, hydrolyzed jojoba esters
, tocopherol (Vitamin E)
, bisabolol
, ectoin
, hydrolyzed viola tricolor extract
, phyllanthus emblica fruit extract
, inulin
, glyceryl caprylate
, mica, iron oxides, caprylhydroxamic acid
, polyhydroxystearic acid, lysolecithin
, sclerotium gum
, xanthan gum
, pullulan
, sodium stearoyl glutamate, sodium riboflavin phosphate, leuconostoc/radish root ferment filtrate
, maltodextrin
, titanium dioxide, silica, citric acid.

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For external use only

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.
Questions?

Email [email protected] or visit www.juicebeauty.com

Active Ingredient

Zinc Oxide 22%

Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

Aloe barbadensis leaf juice

certified organic ingredient
, butyloctyl salicylate, caprylic/capric triglyceride
plant-derived
, polyester-8, glycerin
, cetearyl alcohol
, glyceryl stearate
, glycolipids
, squalane
, sorbitan sesquioleate
, isoamyl laurate
, vitis vinifera (grape) seed oil
, simmondsia chinensis (jojoba) seed oil
, hyaluronic acid, coco-glucoside
, hydrolyzed jojoba esters
, tocopherol (Vitamin E)
, bisabolol
, ectoin
, hydrolyzed viola tricolor extract
, phyllanthus emblica fruit extract
, inulin
, glyceryl caprylate
, mica, iron oxides, caprylhydroxamic acid
, polyhydroxystearic acid, lysolecithin
, sclerotium gum
, xanthan gum
, pullulan
, sodium stearoyl glutamate, sodium riboflavin phosphate, leuconostoc/radish root ferment filtrate
, maltodextrin
, titanium dioxide, silica, citric acid.

Principal Display Panel 50 Ml Tube Carton (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


Advanced Ingredient Data


Raw Label Data

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