Clarifying Line Broad Spectrum Spf 50
FDA Label NDC 53863-124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Exelencia Importers for the product Clarifying Line Broad Spectrum Spf 50 (NDC 53863-124). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings and precautions, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients             Purpose

Octinoxate 7.5% ..........      Sunscreen

Octocrylene 8% ..........       Sunscreen

Oxybenzone 3% ..........     Sunscreen

Titanium Dioxide 3% ......   Sunscreen

Otc - Purpose

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.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

  • Stop use and ask a doctor if rash occurs

Warnings And Precautions

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

Dosage & Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Children under 6 month: ask a doctor
  • 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 AM - 2 PM
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Use a water resistanct sunscreen if swimming or sweating 

Inactive Ingredient

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermun Parkii (Shea Butter) Etract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetaryl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Beanzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (Witch Hazel) Extract, Iron Oxides (C.I. 77.491/77.492/77.499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (Saccharomyces Cerevisiae Extract) 

Package Label.Principal Display Panel

SPF 50+

Broa Specturm SPF 50+

Designed to Apply "Exel Skin Lightening Program"

Contains Ectoin, Vitamin E Acetate

3.30 fl.oz    .      100 ml

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