Mineral Lip Sunscreen Stick
FDA Label NDC 81679-212

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hutton, Kathleen Md for the product Mineral Lip Sunscreen (NDC 81679-212). 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 – 4.5 g tube 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 4.0%

Zinc Oxide 5.5%

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.

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:

  •   - After 80 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 10:00 a.m.-2:00 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

    • Not tested on animals

Principal Display Panel – 4.5 G Tube Label

HUTTON KLEIN

HK
DERMATOLOGISTS

Mineral Lip
Sunscreen

SPF 45

broad spectrum

water resistant

(80 mins)

Tinted

Net. Wt. .14 oz./ 4.5 g

Principal Display Panel – 4.5 G Tube Label (Hut01 0000 01)

Principal Display Panel – 4.5 G Tube Label (Hut01 0000 01)

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