Active Ingredients
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 10.0%
Salt Water Vanilla Sunscreen Body Broad Spectrum Spf 50 Oil
FDA Label NDC 87290-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saltair Body Llc for the product Salt Water Vanilla Sunscreen Body Broad Spectrum Spf 50 (NDC 87290-004). 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 active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
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.
Directions
• apply generously 15 minutes before sun exposure
• reapply: •at 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 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
• children under 6 months of age: Ask a doctor
Inactive Ingredients
Helianthus Annuus Seed Oil, Octyldodecanol, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Polyamide-3, Diisopropyl Adipate, Bis-Octyldecyl Dimer Dilinoleate/Propanediol Copolymer, Fragrance (Parfum), Aleurites Moluccanus Seed Oil, Schinziophyton Rautanenii Kernel Oil, Silica, Tetrahyexyldecyl Ascorbate, Tocopheryl Acetate, Calcium Sodium Borosilicate, Pentaerythrityl Tetra-Di-T-Butyl-Hydroxyhydrocinnamate, Synethtic Fuorphlogopite, Coumarin, Hexyl Cinnamal, Limonene, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491)
Other Information
• protect the product in this container from excessive
heat and direct sun
Questions?
Visit www.Saltair.com
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