Body Butter Broad Spectrum Sunscreen Spf 40
FDA Label NDC 75936-256

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 Body Butter Broad Spectrum Sunscreen Spf 40 (NDC 75936-256). 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%     Sunscreen

Octisalate 5%         Suncreen

Octocrylene 10%    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 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 evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating

    • • 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 your time in the sun, especially from 10
    a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •
    • Children under 6 months of age: ask a doctor.

Inactive Ingredient

Inactive Ingredients

Water, Isododecane, Glycerin, Trimethoxybenzylidene Pentanedione, Polyester-8, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Oryza Sativa (Rice) Bran Extract, Sucrose Stearate, Diisopropyl Sebacate, Hydroxyacetophenone, Isodecyl Neopentanoate, Lauryl Lactate, Sodium Polyacrylate Starch, Diethylhexyl Syringlidenemalonate, Sodium Stearoyl Glutamate, C18-38 Alkyl Hydroxystearoyl Stearate, Chlorphenesin, Ethylhexylglycerin, 1,2 Hexanediol, Caprylyl Glycol, Helianthus Annuus(Sunflower) Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Tocopherol, Romarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Hippophae Rhamnoides Seed Oil, Citrus Nobilis (Manadarin Orange) Peel Oil, Cymbopogon Schoenanthus Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil

Package Label.Principal Display Panel

Supergoop!

Body Butter

SPF 40

Broad Spectrum Sunscreen SPF 40

5.7 fl. oz./168 ml

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