Mineral Sunscreen Stick Spf 50
FDA Label NDC 75936-511

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 Mineral Sunscreen Stick Spf 50 (NDC 75936-511). 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

​Zinc Oxide 17% ............... 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

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

Dosage & Administration

​Directions

  • Apply liberally to face and body at least 15 minutes prior to sun exposure
  • Reapply after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Chlidren under 6 months: 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 take other sun protection measures including:

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

Inactive Ingredient

Inactive Ingredients

Beeswax, Bisabolol,

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Jojoba Esters, Linum Usitatissimum (Linseed) Seed Oil, Octyldodecyl Oleate, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cocao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

Package Label.Principal Display Panel

Supergoop

SPF  50

Water resistant (80 minutes)

100% Mineral Sunscreen Stick

With Avocado Oil

Broad Spectrum SPF 50

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