Label: COOLA CLASSIC FACE SUNSCREEN CUCUMBER BROAD SPECTRUM SPF 30- avobenzone homosalate octisalate octocrylene lotion
- NDC Code(s): 79753-073-02
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 40 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
spectrum SPF of 15 or higher and after 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), Amyris
Balsamifera Bark Oil*, Brassica Campestris
(Rapeseed) Seed Oil, Butylene Glycol, Camelina
Sativa Seed Oil, Caprylyl Glycol, Carthamus
Tinctorius (Safflower) Oleosomes, Carthamus
Tinctorius (Safflower) Seed Oil (ORGANIC),
Cetearyl Alcohol, Cetyl Palmitate, Citric Acid,
Citronellyl Acetate*, Citrus Aurantium Dulcis
(Orange) Peel Oil*, Decanal*, Decyl Glucoside,
Dimethicone, Dimethyl Heptenal*, Glycerin
(ORGANIC), 1,2-Hexanediol, 3-Hexenol*,
Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed
Jojoba Esters, Jojoba Esters, Limnanthes Alba
(Meadowfoam) Seed Oil, Linalyl Acetate*,
Mauritia Flexuosa (Buriti) Fruit Oil, Methyl
Dihydroabietate, Nerol*, Opuntia Ficus-Indica
Flower Extract, Polyacrylate, Crosspolymer-6,
Polysilicone-11, Rubus Idaeus (Raspberry) Seed
Oil, Silica, Sodium Phytate, Sorbitan Oleate,
Sorbitan Palmitate, Squalane, Triethyl Citrate*,
Tropolone, Water, Xanthan Gum - OTHER SAFETY INFORMATION
- QUESTIONS
-
Package Label - COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30
NEEDS OUTER BOX LABELING INSERTED
SPF
3070% +
OrganicCOOLA®
Classic
Face Sunscreen
CucumbarNon-Greasy
Ultralight Hydration
+Plant Protection®Broad Spectrum SPF 30
Water Resistant (40 Minutes).85 FL OZ / 25 mL
2021 COOLA. Distributed by: COOLA LLC,
located in Sunny & Cool San Diego, CA 92010. ,
All Rights Reserved. www.coola.comBox TO DELETE OLD!!!!!!
Tube
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC FACE SUNSCREEN CUCUMBER BROAD SPECTRUM SPF 30
avobenzone homosalate octisalate octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.75 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.75 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) SAFFLOWER OIL (UNII: 65UEH262IS) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRONELLYL ACETATE (UNII: IZ420RT3OY) ORANGE OIL (UNII: AKN3KSD11B) DECANAL (UNII: 31Z90Q7KQJ) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIMETHICONE (UNII: 92RU3N3Y1O) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) 3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) HEXENYL ACETATE, (2Z)- (UNII: PT792BQ57D) HEXYL ACETATE (UNII: 7U7KU3MWT0) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) LINALYL ACETATE (UNII: 5K47SSQ51G) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) NEROL (UNII: 38G5P53250) OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) RASPBERRY SEED OIL (UNII: 9S8867952A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DISODIUM PHTHALATE (UNII: QB14YV193C) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) SQUALANE (UNII: GW89575KF9) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TROPOLONE (UNII: 7L6DL16P1T) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-073-02 1 in 1 CARTON 02/01/2023 1 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2023 Labeler - COOLA LLC (956990290)