Label: COOLA FULL SPECTRUM 360 DAY EYE CREAM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 79753-017-01 - 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 February 3, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
-
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. 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: ● after 80 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 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 1,2-HEXANEDIOL, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice
(ORGANIC), Amino Esters-1(JPN), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carthamus Tinctorius
(Safflower) Oleosomes, Cetearyl Alcohol , Cetyl Palmitate, Coccinia Indica Fruit Extract, Corallina Officinalis Extract,
Corallina Officinalis Powder, Curcuma Longa (Turmeric) Root Extract, Dimethicone, Dimethicone Crosspolymer,
Glycerin (ORGANIC), Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Flower Extract,
Melia Azadirachta Leaf Extract, Neopentyl Glycol Diheptanoate, Ocimum Basilicum (Basil) Flower/Leaf Extract,
Ocimum Sanctum Leaf Extract, Parfum, Polyacrylate Crosspolymer-6, Propanediol, Schinus Molle Extract, Silica,
Sodium Hydroxide, Sodium Phytate, Sodium Polyacrylate, Sodium Melongena (Eggplant) Fruit Extract, Sorbitan
Oleate, Sorbitan Palmitate, Tetrahexyldecyl Ascorbate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone, Water - OTHER SAFETY INFORMATION
- QUESTIONS
-
COOLA Label
SPF
30
70%+ Organic
COOLA®
Day SPF 30 & Night
Eye Cream Duo
Full 360° Spectrum
With Vitamin C & Resveratrol
Stress from Blue Light, Pollution & Fatigue
Broad Spectrum SPF 30
0.8 FL OZ / 24 mL
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &
Cool San Diego, CA 92010. All Rights Reserved. www.coola.com
*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
res
-
INGREDIENTS AND APPEARANCE
COOLA FULL SPECTRUM 360 DAY EYE CREAM SPF 30
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-017 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 2.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALOE VERA FLOWER (UNII: 575DY8C1ER) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL) CORALLINA OFFICINALIS (UNII: 4004498D06) TURMERIC (UNII: 856YO1Z64F) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) HOLY BASIL LEAF (UNII: SCJ765569P) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) PROPANEDIOL (UNII: 5965N8W85T) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) EGGPLANT (UNII: W5K7RAS4VK) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) COCOA (UNII: D9108TZ9KG) TROPOLONE (UNII: 7L6DL16P1T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-017-01 1 in 1 CARTON 02/08/2021 1 24 mL in 1 JAR; 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 02/08/2021 Labeler - COOLA LLC (956990290)