Otc - Active Ingredient
Zinc Oxide - 14.5%
Coola Spf 30 Mineral Sunscreen Fragrance Free Spray
FDA Label NDC 79753-049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coola, Llc for the product Coola Spf 30 Mineral Sunscreen Fragrance Free (NDC 79753-049). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
- Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking.
- Do not use on damaged or broken skin
- When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
- Stop use and ask doctor if skin rash occurs
Otc - 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
• Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied.
• Reapply: • after 80 minutes of swimming or sweating • immediately afrer 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor
Other Safety Information
- May stain fabrics
- Protect this product from excessive heat and direct sun
Inactive Ingredient
Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), WaterSimmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil (ORGANIC), Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Shea Butter Ethyl Esters, Propanediol, Glycerin (ORGANIC), Coco-Glucoside, Laminaria Digitata (Algae) Extract (ORGANIC), Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citric Acid
Otc - Questions
Call 760-940-2125
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