Naturium Phyto-glow Lip Balm Spf 45-oasis Cream
FDA Label NDC 76354-137

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by E.l.f. Cosmetics, Inc. for the product Naturium Phyto-glow Lip Balm Spf 45-oasis (NDC 76354-137). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 3%

Octisalate 5%

Purpose

Sunscreen

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.

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.

Stop Use And Ask A Doctor If:

  • rash occurs.

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Use 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in 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.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactiveingredients

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Aroma/Flavor, Polyglyceryl-2 Diisostearate, Butyrospermum Parkii (Shea) Butter, Cera Microcristallina/Microcrystalline Wax/Cire Microcristalline, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Synthetic Wax, Mica, Squalane, Theobroma Grandiflorum Seed Butter, Siraitia Grosvenorii Fruit Extract, Tocopherol, Citric Acid, BHT, Carvone, Cinnamal, Eugenol, Limonene, Menthol, Methyl Salicylate, Vanillin.

Questions?

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