Label: COOLA SPF 50 CLASSIC- sunscreen face mist spray
- NDC Code(s): 79753-033-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only.
Flammable: 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 out of eyes. Rinse with water to remove.
Stop use and ask doctor if skin rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
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Directions
SHAKE WELL before use.
With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.
Wait until dry.
Apply liberally 15 minutes before sun exposure.
Reapply:
-After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:
-Limit time in the sun, especially from 10 a.m. – 2 p.m.
-Wear long sleeves shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.
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Inactive Ingredients
Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate
- Other Information
- Questions or Comments
- Package Label
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INGREDIENTS AND APPEARANCE
COOLA SPF 50 CLASSIC
sunscreen face mist sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) SAFFLOWER OIL (UNII: 65UEH262IS) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) VINYL ACETATE (UNII: L9MK238N77) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) DIBUTYL MALEATE (UNII: 4X371TMK9K) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) DICAPRYL SUCCINATE (UNII: 8XD1ZF2M1M) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) LEVOMENOL (UNII: 24WE03BX2T) ETHYL FERULATE (UNII: 5B8915UELW) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA) RASPBERRY SEED OIL (UNII: 9S8867952A) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-033-01 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2021 Labeler - COOLA LLC (956990290)
