House Of Colour Tinted Sunscreen Spf 50 Cream
FDA Label NDC 85242-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by House Of Colour, Inc. for the product House Of Colour Tinted Sunscreen Spf 50 (NDC 85242-000). 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 active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc oxide 24%

Purpose

Sunscreen

Use

helps prevent sunburn

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • 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 of age: Ask a doctor. 

Other Information

protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Hydroxyacetophenone, Water, Panthenol, Argan Oil, C10-18 Triglycerides, Medium Chain Triglycerides, Iron Oxides, Isododecane, Polyglyceryl-6 Polyhydroxystearate, Polyhydroxystearic acid, Tocopherol, VP/Eicosene Copolymer, Glycerin, Magnesium Sulfate, Niacinamide, Tocopheryl Acetate, Trihydroxystearin , 1,2-Hexanediol, Bisabolol, Caprylyl Glycol, Allantoin, Ascorbyl Palmitate, Green Tea Leaf Extract, Coco-caprylate, Glyceryl Behenate, Polyglyceryl-6 Polyricinoleate, Triethoxycaprylylsilane.

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