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  5. Label Information: Spf 50 Moisturizing Sunscreen Broad Spectrum

FDA Label for Spf 50 Moisturizing Sunscreen Broad Spectrum

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spf 50 Moisturizing Sunscreen Broad Spectrum Product Label

The following document was submitted to the FDA by the labeler of this product Gate Therapeutics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients                            Purpose

Octinoxate 6%, Zinc Oxide 12%       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



Stop use and ask a doctor if rash occurs


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.


Dosage & Administration



Directions
• Apply liberally 15 minutes before sun exposure

• Reapplyat least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10a.m. – 2p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under six months consult a physician


Inactive Ingredient



Inactive ingredients   ​​Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol


Package Label.Principal Display Panel



SPF 50+

Moisturizing Sunscreen

Broad Spectrum Daily Use

1Fl Oz/30 mL

Tube 1 oz - 1OZ tube spf50

Tube 1 oz - 1OZ tube spf50


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