Active Ingredients Purpose
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Avobenzone 3% Sunscreen
Spf 30 Sunscreen Spray
FDA Label NDC 85033-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coconut Caliente Costa Rica Llc for the product Spf 30 Sunscreen (NDC 85033-003). 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, directions, warnings for external use only., keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps prevent sunburn
Directions
Apply evenly to face and neck 15 minutes before sun
exposure reapply: After 80 minutes of swimming or sweating .
Immediately after towel drying . At least every 2 hours • 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
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.
Warnings For External Use Only.
Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away.
Inactive Ingredients
Alcohol Denat.
Aloe Barbadensis Leaf Extract
Ascorbyl Palmitate
Butyloctyl Salicylate
Daucus Carota Sativa (Carrot) Root Extract
Fragrance
Helianthus Annuus (Sunflower) Seed Oil
Mangifera Indica (Mango) Seed Butter
Mineral Oil
Oryza Sativa (Rice) Bran Oil
Phospholipids
Polyester-8
Retinyl Palmitate
Rubus Idaeus (Red Raspberry) Seed Oil
Sodium Hyaluronate
Water
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