Shine On Lip Sunscreen
FDA Label NDC 75936-141

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 Shine On Lip Sunscreen (NDC 75936-141). 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

Homosalate 10% ............ Sunscreen

Octinoxate 7.5% ............ Sunscreen

Octisalate 5% ................ Sunscreen

Otc - Purpose

Uses

  • Helps prevent and tempararily protect chafed, chapped, cracked, or windburned skin and/or lips
  • 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

Children under 6 months: Ask a doctor

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 liberally 15 minuts before sun exposure
  • Reapply after 80 minuts of swimming or sweating
  • Immediately after towel drying
  • At least every two hours

    • 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 10a.m. - 2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredient

Inactive Ingredients

Hydrogenated Polyisobutene, Butyloctyl Salicylate, Polyester-7, Diisopropyl Sebacte, Isodecyl Neopentanoate, Lauryl Lactate, Neopentyl Glycol Diheptanoate, Polyester-8, Tibehenin, Phenoxyethanol, Trihydroxystearin, Menthone Glycerin Acetal, Diethylhexy Syringylidenemalonate, Polybutene, Tocopheryl Acetate, Polysilicone-15, Octyldodecanol, Elaeis Guineensis (Palm) Oil, Benzoic Acid, Tocotrienols, Helianthus Annuus (Sunflower) Seed Oil, Dehydroacetic Acid, Tocopherol, Caprylic/Capric Triglyceride, BHT, Vits Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract 

Package Label.Principal Display Panel

Shine-On!

Lip Screen

With Grape Polyphenols

Broa Spectrum SPF 50

Supergoop!

Water resistant

(80 minutes)

0.14 fl. oz. / 4 ml.

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