COOLA REFRESHING WATER PLUMPING GEL SERUM SPF 30- avobenzone, homosalate, octisalate, octocrylene gel

COOLA Refreshing Water Plumping Gel Serum SPF 30 by

Drug Labeling and Warnings

COOLA Refreshing Water Plumping Gel Serum SPF 30 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%

Purpose

Suncreen

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
● apply liberally 15 minutes before sun exposure.
● reapply at least every 2 hours
● use a water resistant sunscreen if wimming or sweating
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
spection 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

INACTIVE INGREDIENT

Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Alcohol Denat (ORGANIC),
Ammonium Acryloyldimethyltaurate/VP Copolymer Butyloctyl
Salicylate, Ethylhexyl Methoxycrylene, Hyaluronic Acid, Cocos Nucifera
(Coconut) Fruit Water (ORGANIC), Alaria Esculenta Extract, Aloe
Barbadensis Flower Extract, Jasminum Sambac (Jasmine) Leaf Cell
Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,
Corallina Officinalis Extract, Coccinia Indica Fruit Extract, Solanum
Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed
Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum
(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus
Molle Extract, Caprylic/Capric Triglyceride, Water, Ethyl Ferulate,
Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Triethyl
Citrate*, Tapioca Starch, Glycerin, Gamma-Nonalactone*, Tropolone,
Juniperus Mexicana Oil*, Gamma-Octalactone*, Benzyl Acetate*,
Phenylethyl Alcohol*, Mimosa Tenuiflora Bark Extract*, Vanillin*,
Heliotropine*, Anisaldehyde*, Delta-Decalactone*, Methylbenzyl
Acetate*, Ethyl Butyrate*, Methyl Anthranilate*, Methyl Benzoate*

*Plant derived scent constituent. See coola.com for additional detail.

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call 760-940-2125

COOLA Refreshing Water Plumping Gel Serum - Labeling

COOLA®
Refreshing Water
Plumping Gel Serum
Sunscreen

Broad Spectrum SPF 30

©2024 COOLA
Manufactured in the USA for
COOLA LLC, located in sunny
San Diego, CA 92009.
All Rights Reserved.
www.coola.com

Carton

Bottle

Tube

Sachet

res

INGREDIENTS AND APPEARANCE

COOLA REFRESHING WATER PLUMPING GEL SERUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
HYALURONIC ACID (UNII: S270N0TRQY)
COCONUT WATER (UNII: 267F5Y81NT)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
CORALLINA OFFICINALIS (UNII: 4004498D06)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
EGGPLANT (UNII: W5K7RAS4VK)
COCOA (UNII: D9108TZ9KG)
TURMERIC (UNII: 856YO1Z64F)
HOLY BASIL LEAF (UNII: SCJ765569P)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
ETHYL FERULATE (UNII: 5B8915UELW)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, TAPIOCA (UNII: 24SC3U704I)
GLYCERIN (UNII: PDC6A3C0OX)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
TROPOLONE (UNII: 7L6DL16P1T)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
VANILLIN (UNII: CHI530446X)
PIPERONAL (UNII: KE109YAK00)
P-ANISALDEHYDE (UNII: 9PA5V6656V)
.DELTA.-DECALACTONE (UNII: CNA0S5T234)
METHYLBENZYL ACETATE (UNII: P4RVP859F5)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
METHYL BENZOATE (UNII: 6618K1VJ9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-081-01	1 in 1 CARTON	01/01/2024
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 79753-081-02	7 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2024
3	NDC: 79753-081-03	2.5 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

Labeler - COOLA LLC (956990290)

Registrant - COOLA LLC (956990290)