Otc - Active Ingredient
Avobenzone – 3.0%
Octisalate – 4.0%
Octocrylene – 8.0%
Coola Dew Good Illuminating Body Melt Spf 40 Cream
FDA Label NDC 79753-082
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 Dew Good Illuminating Body Melt Spf 40 (NDC 79753-082). 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
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
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 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
• Apply liberally 15 minutes before sun exposure
• Reapply: • After 40 minutes of swimming or sweating.
• Immediately after towel drying. • Apply 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 10 a.m. to 2 p.m. • Wear long-sleeved shirts, pants,
hats, and sunglasses. • Children under 6 months: Ask a doctor.
Other Safety Information
Other information • Protect this product from excesssive
heat and direct sun • May stain fabrics
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Carthamus Tinctorius (Safflower),
Oleosomes (ORGANIC), Water, Caprylic/Capric Triglyceride (ORGANIC), Cocos
Nucifera (Coconut) Oil (ORGANIC), Ethylhexyl Methoxycrylene, Methyl
Dihydroabietate, Mica, Glycerin (ORGANIC), Glyceryl Stearate,
Stearyl/Octyldodecyl Citrate Crosspolymer, Polyacrylate Crosspolymer-6,
Butyrospermum Parkii (Shea) Butter (ORGANIC), Lactobacillus Ferment, Sodium
Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethyl Ferulate,
Caprylyl Glycol, 1,2-Hexanediol, Titanium Dioxide, Stearic Acid, Sodium Stearoyl
Glutamate, Dimethicone, Sodium Phytate, Xanthan Gum, Maltodextrin, Sodium
Hydroxide, Polysilicone-11, Butylene Glycol, Tropolone,
Decyl Glucoside, Fragrance (Natural)
Otc - Questions
Questions or Comments? Call 760-940-2125
Package Label.Principal Display Panel
Dew Good
Illuminating Body Melt
Sunscreen Lotion
Broad Spectrum SPF 40
3.4 FL. OZ. / 100 mL
2024 COOLA. Manufactured in the USA for COOLA LLC,
located in sunny San Diego, CA 92009
www.coola.com
reg
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