Prebiotix Spf 45 Glow
FDA Label NDC 55165-0301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Juice Beauty for the product Prebiotix Spf 45 Glow (NDC 55165-0301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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 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.

Other Information

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

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)

Principal Display Panel (50 mL Tube Carton)

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