Defense Refresh Setting Mist Broad Spectrum Sunscreen Spf 50
FDA Label NDC 75936-134

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd for the product Defense Refresh Setting Mist Broad Spectrum Sunscreen Spf 50 (NDC 75936-134). 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 2.8%   Sunscreen

Homosalate 9.8%    Sunscreen

Octisalate 4.9%       Sunscreen

Octocrylene 9.5%    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 of reach of children

If product is 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

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 generously and evenly15 minutes before sun exposure

Reapply:

  • after 40 minutes of swimming or sweating
    • immediately after towel drying
      • at least every 2 hours

        • Sun Protection Measures: Spending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

        • Limit time in the sun, especially from 10 a.m.-2p.m.
          • Wear long-sleeved shirts, pants, hats, and sunglasses

            • Reapply at least every 2 hours

            • Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients Alcohol Denat., Bisabolol, Brassica Compestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl syringlidenemalonate, Diheptyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate

Package Label.Principal Display Panel

Supergoop!

Defense (RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SPF 40

Water and Sweat Resistant (40 minutes)

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