Skin Balancing Ultra Sheer Daily Defence Spf 30 Cream
FDA Label NDC 56152-5001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd for the product Skin Balancing Ultra Sheer Daily Defence Spf 30 (NDC 56152-5001). 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, 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

Avobenzone 3.0% ........... Sunscreen
Homosalate 7.0% ............ Sunscreen

Octocrylene 2.0% ............ Sunscreen

Oxybenzone 4.0% ............ 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 sun.

Otc - Keep Out Of Reach Of Children

Keep out of 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

Warnings

For external use only.

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

Dosage & Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a  water-resistant sunscreen if swimming or sweating:
  •       Imeediately after towel drying
  •       At least every two hours
  • Children under 6 months of age: 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 of 15 or higher and other sun protection measures, including:

    • Limit time in the sun, especially from 10AM - 2PM
    • Wear long-sleeve shirts, pants, hats and sunglasses

Inactive Ingredient

Water (Aqua), Butylene Glycol, Silica, Aluminum Starch Octenylsuccinate, Cetyl Dimethicone, Camelia Sinensis (Green Tea) Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Phospholipids, Superoxide Dismutase, Adenosine, Tocopherol, Bisabolol, Boerhavia Diffusa Root Extract, Colloidal Oatmeal, Panthenol, Ginkgo Biloba Leaf Extract, Salix Alba (Willow) Bark Extract, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Titanium Dioxide, Sodium Hydorxide, Steareth-21, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sorbic Acid

Package Label.Principal Display Panel

Paula's Choice

Skin Balancing Ultra-Sheer Daily Defense

Broad Spectrum SPF 30


60ml / 2 fl. oz.

Image Description (1560 Component)

Image Description (1560 Component)

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