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Drug Facts
Mineral Tinted Face Sunscreen Spf 30 - Light/ Medium
FDA Label NDC 73455-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unsun Cosmetics for the product Mineral Tinted Face Sunscreen Spf 30 - Light/ Medium (NDC 73455-011). 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, otc - purpose, uses, skin cancer/skin aging alert, otc - keep out of reach of children, directions, non-medicinal ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Medicinal ingredients | Purpose |
|---|---|
| Titanium dioxide 5.5% | Sunscreen |
| Zinc oxide 6.5% | 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
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging For external use only. Do not use on damaged or broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Directions
Adults and children over 6 months of age: Apply liberally and evenly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or perspiring heavily or immediately after towel drying or washing, at least every 2 hours. Children under 6 months of age: 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.– 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
Non-Medicinal Ingredients
Water/Aqua/Eau, Caprylic/Capric Triglyceride, Isoamyl Laurate, Glycerin, Polyglyceryl-2 Sesquioleate, Coconut Alkanes, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica (Abyssinian) Seed Oil, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Heptyl Undecylenate, Alumina, Stearic Acid, Magnesium Sulfate, Sodium Chloride, Coco-Caprylate/Caprate, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Juice, Beeswax/Cera Alba/Cire d' Abeille, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Ascorbic Acid, Beta Vulgaris (Beet) Root Extract, Citric Acid, Citrus Aurantium Amara (Bitter Orange) Fruit Extract, Citrus Aurantium Sinensis Peel Extract, Citrus Reticulata (Tangerine) Fruit Extract, Glycine Soja (Soybean) Oil, Hydrolyzed Corn Starch, Lactic Acid, p-Anisic Acid, Tocopherol, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).
Other Information
- protect this product from excessive heat and direct sun
Principal Display Panel - 50 Ml Tube Label - Light Medium
unsun™
MINERAL TINTED
FACE SUNSCREEN
LOTION
30
BROAD SPECTRUM
SPF 30
WATER RESISTANT
(80 MINUTES)
NPN xxxxx
LIGHT - MEDIUM
1.7 FL OZ | 50 mL
Principal Display Panel (50 mL Tube Label)
Principal Display Panel - 50 Ml Tube Label - Medium Dark
unsun™
MINERAL TINTED
FACE SUNSCREEN
LOTION
30
BROAD SPECTRUM
SPF 30
WATER RESISTANT
(80 MINUTES)
NPN xxxxx
MEDIUM - DARK
1.7 FL OZ | 50 mL
Principal Display Panel (50 mL Tube Label)
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