Face And Body Mineral Spf - Tinted
FDA Label NDC 81535-210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Flawless Skin Care, Llc (dba Abby Skin Clinic) for the product Face And Body Mineral Spf - Tinted (NDC 81535-210). 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 active ingredients:, purpose:, uses:, warnings:, directions:, inactive ingredients:, other information:, principal display panel - 100 g can label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Purpose:

Sunscreen

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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Shake well before using.
  • Push nozzle up to release safety tab.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of 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 value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 am-2 pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-TetrafIuoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,Trimethoxycaprylylsilane, Water

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Store between 68° to 104° F (20° to 40° C).
  • Do not store at temperatures above 120° F.

Principal Display Panel - 100 G Can Label

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FACE & BODY
MINERAL SPF
TINTED

Oil Free Mousse Sunscreen

broad spectrum SPF 30

water resistant (40 mins)

  • Great for all skin types
  • Photo-stable will not degrade in sunlight
  • FREE of chemical sunscreen filters, dyes,
    fragrances, oils and preservatives
  • Reef friendly
  • non-comedogenic

    • Net Wt. 3.5 oz | 100 g

    Principal Display Panel (100 g Can Label)

    Principal Display Panel (100 g Can Label)

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