Label: COOLA REFRESHING WATER MIST SPF 18- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 79753-079-02
- 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 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• shake well • apply liberally 15 minutes before sun exposure
• reapply: •after 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 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,
Tridecane, Water, Cocos Nucifera (Coconut) Water
(ORGANIC), Sodium Hyaluronate, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)
Seed Extract, Schinus Molle Extract, Heliotropine*,
Juniperus Mexicana*, Propanediol, Butylene Glycol,
Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl
Glycol, Polyquaternium-80, Sodium Phytate,
Didecyldimonium Chloride, Anisaldehyde*, Benzyl
acetate*, Delta-Decalactone*, Gamma-Nonalactone*,
Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl
Butyrate*, Triethyl citrate*, Vanillin* Plant-derived scent constituent.
- OTHER SAFETY INFORMATION
- QUESTIONS
- Product Label - COOLA Refreshing Water Mist Sunscreen SPF 18
-
INGREDIENTS AND APPEARANCE
COOLA REFRESHING WATER MIST SPF 18
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) UNDECANE (UNII: JV0QT00NUE) TRIDECANE (UNII: A3LZF0L939) WATER (UNII: 059QF0KO0R) COCONUT WATER (UNII: 267F5Y81NT) HYALURONATE SODIUM (UNII: YSE9PPT4TH) JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID) COCOA (UNII: D9108TZ9KG) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) PIPERONAL (UNII: KE109YAK00) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) METHYLPROPANEDIOL (UNII: N8F53B3R4R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYQUATERNIUM-80 (UNII: 3N8LGV97HR) PHYTATE SODIUM (UNII: 88496G1ERL) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) P-ANISALDEHYDE (UNII: 9PA5V6656V) BENZYL ACETATE (UNII: 0ECG3V79ZJ) .DELTA.-DECALACTONE (UNII: CNA0S5T234) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) METHYL BENZOATE (UNII: 6618K1VJ9T) NEROLIDOL (UNII: QR6IP857S6) ETHYL BUTYRATE (UNII: UFD2LZ005D) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VANILLIN (UNII: CHI530446X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-079-02 1 in 1 CARTON 02/01/2023 1 25 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2023 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753)