Otc - Active Ingredient
Active Ingredients
Zinc Oxide 12.0015%
Milk Tint Spf 43 Tinted Primer Serum Light Lotion
FDA Label NDC 68577-165
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Milk Tint Spf 43 Tinted Primer Serum Light (NDC 68577-165). 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, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Uses
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 cause by the sun
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if
- rash or irritation develops and lasts
Otc - When Using
When using this productkeep out of eyes. Rinse with water to remove.
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
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months of age: ask a doctor
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Sun Protection Measures
Spending time in the sun increases you 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:
Inactive Ingredient
Water (Aqua), Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Methylpropanediol, Isopropyl Isostearate, Niacinamide, Sodium Chloride, Polyglyceryl-6 Polyricinoleate, Silica, Sorbitan Sesquiisostearate, Caprae Lac (Goat Milk), Bifida Ferment Lysate, Milk Protein, Eryngium Alpinum (Blue Thistle) Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Sambucus Nigra (Elderberry) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydroxyacetophenone, Mica, 1,2-Hexanediol, Caprylyl Glycol, Lauroyl Lysine, Glycerin, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Lactose May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
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