Lip And Cheek Treat Broad Spectrum Spf 40
FDA Label NDC 75936-503

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 Lip And Cheek Treat Broad Spectrum Spf 40 (NDC 75936-503). 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%, Homosalate 10%,

Octinoxate 7.5%, Octisalate 5% ....... Sunscreen

Otc - Purpose

Uses

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

  • Helps prevent subnurn
  • If use as directed with other sun pretction 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 Posion Control Center right away
  • If condition worsens or does not improve within 7 days, consult a doctor

Dosage & Administration

Directions

Apply liberally 15 minutes before sun exposure

  • Reapply liberally as oftenas necessary
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children 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 other sun protection measures including:

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

Inactive Ingredient

Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Synthetic Beeswax, Microcrystalline Wax, Polyester-8, Ozokerite, Silica, VP/Hexadecene Copolymer, Ricinus Communis (Castor) Seed Oil, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Hydorgenated Vegetable Oil, Phenoxyethanol, Diethylhexyl Syringylidenemalonate, Titanium Dioxide, Red 7, Tocopherol, Glycine Soja (Soybean) Oil, Yellow 5 Lake, Benzoic Acid, Polysilicone-15, Helianthus Annuus (Sunflower) Seed Oil, Dehydoacetic Acid, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Citric Acid, BHT, Olea Europaea (Olive) Fruit Oil, Pesea Gratissima (Avocado) Oil, Camellia Sinensis Leaf Extract, Water, Calendula Officinalis Flower Extract, Salicylic Acid, Sodium Hydroxide

Package Label.Principal Display Panel

Perk Up

Lip & Cheek Treat

Broad Spectrum Sunscreen SPF 40

0.06 oz./ 4.5g

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