Label: COOLA FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream
- NDC Code(s): 79753-020-01, 79753-020-02
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• 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 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
Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)
Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,
Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera
(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,
Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,
Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus
Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower
Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa
Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum
Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium
Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma
Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum - OTHER SAFETY INFORMATION
- QUESTIONS
-
COOLA Label
SPF
50
70%+
Organic
COOLA®
Refreshing Water Cream
Sunscreen
1.5 FL OZ / 44 mL
Broad Spectrum SPF 70
Water Resistant (80 Minutes)
5.0 FL OZ / 148 mL
©2021 COOLA. Distributed by: COOLA LLC, located in
Sunny & Cool San Diego, CA 92010. All Rights Reserved.
†Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.Carton
Bottle
res
-
INGREDIENTS AND APPEARANCE
COOLA FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-020 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 5.0 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 ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) ALOE VERA FLOWER (UNII: 575DY8C1ER) ALOE VERA LEAF (UNII: ZY81Z83H0X) P-ANISALDEHYDE (UNII: 9PA5V6656V) ARGAN OIL (UNII: 4V59G5UW9X) BENZYL ACETATE (UNII: 0ECG3V79ZJ) LEVOMENOL (UNII: 24WE03BX2T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL) COCONUT WATER (UNII: 267F5Y81NT) CORALLINA OFFICINALIS (UNII: 4004498D06) TURMERIC (UNII: 856YO1Z64F) .DELTA.-DECALACTONE (UNII: CNA0S5T234) ETHYL BUTYRATE (UNII: UFD2LZ005D) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PIPERONAL (UNII: KE109YAK00) HYALURONIC ACID (UNII: S270N0TRQY) ISODODECANE (UNII: A8289P68Y2) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) METHYL ANTHRANILATE (UNII: 981I0C1E5W) METHYL BENZOATE (UNII: 6618K1VJ9T) METHYLBENZYL ACETATE (UNII: P4RVP859F5) MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) NEROLIDOL (UNII: QR6IP857S6) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) HOLY BASIL LEAF (UNII: SCJ765569P) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PROPANEDIOL (UNII: 5965N8W85T) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) EGGPLANT (UNII: W5K7RAS4VK) COCOA (UNII: D9108TZ9KG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-020-01 1 in 1 CARTON 02/08/2021 1 44 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:79753-020-02 1 in 1 CARTON 02/08/2021 2 15 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 Drug M020 02/08/2021 Labeler - COOLA LLC (956990290)