COOLA REFRESHING WATER MIST SPF 18- avobenzone, homosalate, octisalate, octocrylene spray

COOLA Refreshing Water Mist SPF 18 by

Drug Labeling and Warnings

COOLA Refreshing Water Mist SPF 18 by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Avobenzone 2.0%. Homosalate 10.0%

Octisalate 5.0%, Octocrylene 5.5%

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

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

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

Other information

protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call 760-940-2125

COOLA Label

COOLA​®​

Refreshing Water Mist

Sunscreen

SPF 18

Alcohol-Free

Broad Spectrum SPF 18

1.7 FL OZ / 50 mL

Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92009

www.coola.com

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INGREDIENTS AND APPEARANCE

COOLA REFRESHING WATER MIST SPF 18 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-148
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: 54111-148-50	1 in 1 CARTON	07/30/2020
1		50 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 Drug	M020	07/30/2020

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-148)