FDA Label for Broad Spectrum Spf45

View Indications, Usage & Precautions

Broad Spectrum Spf45 Product Label

The following document was submitted to the FDA by the labeler of this product Drmtlgy, Llc. 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.

Drug Facts




Active Ingredients



Zinc Oxide 12%

Octinoxate 7.5%


Purpose



Sunscreen


Uses



Helps prevent sunburn. • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.


Warnings



For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.


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



• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours. 


Precautions



• 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 value of SPF 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. Children under 6 months of age: Ask a physician.


Inactive Ingredients:



Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane


Questions Or Comments?



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