COOLA DEW GOOD ILLUMINATING BODY MELT SPF 40- avobenzone, octisalate, octocrylene cream

COLA Dew Good Illuminating Body Melt SPF 40 by

Drug Labeling and Warnings

COLA Dew Good Illuminating Body Melt SPF 40 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone – 3.0%
Octisalate – 4.0%
Octocrylene – 8.0%

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

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)

QUESTIONS

Questions or Comments? Call 760-940-2125

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

100 mL Bottle

7 mL Tube

res

INGREDIENTS AND APPEARANCE

COOLA DEW GOOD ILLUMINATING BODY MELT SPF 40 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-082
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SAFFLOWER (UNII: 4VBL71TY4Y)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SHEA BUTTER (UNII: K49155WL9Y)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ETHYL FERULATE (UNII: 5B8915UELW)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHYTATE SODIUM (UNII: 88496G1ERL)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROPOLONE (UNII: 7L6DL16P1T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-082-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/24/2024
2	NDC: 79753-082-02	7 mL in 1 TUBE; Type 0: Not a Combination Product	06/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/24/2024

Labeler - COOLA LLC (956990290)