Other
sunscreen sprays
Sunscreen Sprays
FDA Label NDC 82080-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Headblock Llc for the product Sunscreen Sprays (NDC 82080-101). 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 other, active ingredient(s), purpose, use, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
ETHYLHEXYL METHOXYCINNAMATE 5% w/w. Purpose: Sunscreen
Purpose
Sunscreen, sunscreen sprays
Use
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
Spray away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away. Caution: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate.Store at temperature below 120F (48℃). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Directions
Shake well before use. Apply liberally 15 minutes before sun exposure and rub into skin. Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in well-ventilated area. Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, or at least every 2 hours. Children under 6 months: Ask a doctor. Other Information: protect this product from excessive heat and direct sun; may stain some fabrics.
Other Information
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.
Inactive Ingredients
Butane,propane, isobutene, water, cyclopentasiloxane, isohexadecane, alcohol, zincoxide, silica, triethoxycaprylylsilane cyclopentasiloxane, peg/ppg-18/18 dimethicone, dimethicone, methylene bis-benzotriazolyl tetramethylbutylphenol, decyl glucoside, propylene glycol, xanthan gum, C12-15 alkyl benzoate, phenylbenzimidazole sulfonic acid, dioctyldodecyl lauroyl glutamate, polysilicone-15,sodium chloride, sodium hydroxide, cetyl peg/ppg -10/1 dimethicone, butylene glycol, centella asiatica extract, polygonum cuspidatum root extract, polygonum cuspidatum root extract,scutellaria baicalensis root extract,camellia sinensis leaf extract, glycyrrhiza glabra,(licorice) root extract, rosmarinus officinalis (rosemary) leaf extract, chamomilla recutita(matricaria) flower extract, 1,2-hexanediol, phenoxyethanol, citrus paradisi (grapefruit) peel oil, tocopherol,disodium edta
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