Sunnydays Broad Spectrum Spf 30 Tinted Sunscreen Lotion
FDA Label NDC 81899-015

29 label sections · Submitted to the FDA by Tower 28 · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tower 28 for the product Sunnydays Broad Spectrum Spf 30 Tinted Sunscreen (NDC 81899-015). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

DIST. BY
TOWER 28 BEAUTY, INC.
SANTA MONICA, CA 90405

Active Ingredient

Zinc oxide, 12.6%

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

Otc - Do Not Use

Do not useon damaged or broken skin.

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctorif skin rash occurs.

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.

Directions

  • apply liberally and evenly 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:
    • immediately after towel drying
    • 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 of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

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

Inactive Ingredients

Water/Aqua/Eau, Isononyl Isononanoate, C9-12 Alkane, Butyloctyl Salicylate, Polyglyceryl-6 Polyricinoleate, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl Methoxycrylene, Trimethylsiloxysilicate, Mica, Polyglyceryl-2 Isostearate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Isostearic Acid, Lecithin, Polyglyceryl-6 Polyhydroxystearate, Jojoba Esters, Ethylhexylglycerin, Sodium Phytate, Aloe Barbadensis Leaf Water, Centella Asiatica Extract, Opuntia Tuna Fruit, Salvia Officinalis (Sage) Extract, May Contain (+/-): Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

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