Lipidol
FDA Label NDC 69359-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Union-swiss (pty) Ltd for the product Lipidol (NDC 69359-000). 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, dosage & administration, warnings, 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 6%

Octisalate 5%

Octocrylene 6.5% ............................... Sunscreen

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Lipidol 

Sunscreen Broad Spectrum SPF 20

4.2 fl. oz.

Dosage & Administration

Directions
apply liberally 15 minutes before sun exposure
reapply:

  • at least every 2 hours
  • immediately after towel drying

    • use a water resistant sunscreen if swimming or sweating
    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.-2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

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.

Stop use and ask a doctor if rash occurs.

Inactive Ingredient

Inactive Ingredients

mineral oil (paraffinum liquidum), isopropyl palmitate, cetearyl ethylhexanoate, C12-15 alkyl benzoate, oryxanol, bisabolol, tocopheryl acetate, pyridoxine dipalmitate, octyldodecyl PCA, phytosterols, carthamus tinctorius (safflower) seed oil, borago officinalis (borage) seed oil, linoleic acid, linolenic acid, butylene glycol, BHT, cupressus simpervirens oil, ocimum basilicum (basil) oil, melia azadirachta leaf extract, melia azadirachta flower extract, aspartic acid, arginine, glycine, glutamic acid, histidine, coccinia indica fruit extract, solanum melongena (eggplant) fruit extract, aloe barbadensis flower extract, lawsonia inermis (henna) flower/fruit/leaf extract, ocimum sanctum leaf extract, ocimum basilicum (basil) flower/leaf extract, curcuma longa (turmeric) root extract, corallina officinalis extract, simmondsia chinensis (jojoba) seed oil, farnesol, limonene

Package Label.Principal Display Panel

Image Description (Lipidol)

Image Description (Lipidol)

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