Hydra Spf 34 Stick
FDA Label NDC 83286-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drmtlgy, Llc for the product Hydra Spf 34 (NDC 83286-017). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate 10.00%
Octyl Salicylate 5.00%
Avobenzone 3.00%
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. Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor 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 liberally 15 minutes before sun exposure • Reapply: • After 40 minutes of swimming sweating • Immediately after towel drying • 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.
Inactive Ingredients
Caprylic/Capric Triglyceride, Coconut (Cocos Nucifera) Oil, Methyl Methacrylate Crosspolymer, Polyethylene, Dimethicone, Diethylhexyl Syringylidenemalonate, Nylon-12, Squalene, Aloe (Aloe Vera) Leaf Extract, Edelweiss (Leontopodium Nivale) Flower/Leaf Extract, Calendula (Calendula Officinalis) Flower Extract, Soybean (Glycine Soja) Oil, Rice (Oryza Sativa) Bran Extract, Polyglyceryl-3 Diisostearate, Stearalkonium Hectorite, Rice (Oryza Sativa) Extract, Rice (Oryza Sativa) Germ Extract, Sunflower (Helianthus Annuus) Extract, Propylene Carbonate, Rosemary (Rosmarinus Officinalis) Leaf Extract, Tocopherol, Sunflower (Helianthus Annuus) Seed Oil
Questions Or Comments?
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Packaging
Hydra Spf 34 (83286017 8)
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