Active Ingredient:
Zinc Oxide 18.8%
Ultra Sheer Mineral Sunscreen Pro Spf30 Lotion
FDA Label NDC 72113-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eden Brands Inc. for the product Ultra Sheer Mineral Sunscreen Pro Spf30 (NDC 72113-112). 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 statement of identity, active ingredient:, purpose:, uses:, warnings:, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
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
Otc - Do Not Use
• Do not use on damaged or broken skin.
Otc - Stop Use
• Stop use and ask a doctor if rash occurs
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children.
Directions:
• Shake well before use.
• Apply liberally to face and body 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.
• 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 your time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredients:
Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Squalane, C13-15 Alkane, Polyglyceryl-4 Laurate, Hydroxyapatite, Persea Gratissima (Avocado) Oil, Polyglyceryl-6 Laurate, Isoamyl Laurate, Propanediol, Polyhydroxystearic Acid, 1,2-Hexanediol, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Citrate, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Maris Limus Extract, Sclerotium Gum, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Glycine Soja (Soybean) Seed Extract, Magnolia Officinalis Bark Extract, Chondrus Crispus Extract, Pongamia Pinnata Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Glabra Seed Oil, Trisodium Ethylenediamine Disuccinate, Chimyl Alcohol, Tasmannia Lanceolata Leaf Extract, Hydroxyacetophenone, Sorbitan Isostearate, Phenylpropanol, Caprylyl Glycol, Tocopherol, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Sodium Hyaluronate, Naringin
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