Label: COOLA CLEAR SKIN OIL-FREE MOISTURIZER SPF 30- zinc oxide sunscreen cream
- NDC Code(s): 79753-080-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
● apply liberally 15 minutes before sun exposure.
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming 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 spectrum 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), Caprylic/Capric
Triglyceride (ORGANIC), Glycerin (ORGANIC), Glyceryl
Stearate Citrate, Niacinamide, Butylene Glycol, Butyloctyl
Salicylate, Ethylhexyl Methoxycrylene, Hydroxyethyl
Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Water, Jasminum Sambac (Jasmine) Leaf Cell Extract,
Theobroma Cacao (Cocoa) Seed Extract, Centella Asiatica
Leaf Extract, Tropolone, Schinus Molle Extract, Isostearic
Acid, Citric Acid (ORGANIC), Polyhydroxystearic Acid,
Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer,
Isoamyl Laurate, 1,2-Hexanediol, Caprylyl Glycol,
Tocopheryl Acetate, Sodium Phytate - OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- COOLA Clear Skin Oil-Free Moisturizer SPF 30 Label
-
INGREDIENTS AND APPEARANCE
COOLA CLEAR SKIN OIL-FREE MOISTURIZER SPF 30
zinc oxide sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 14.7 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) WATER (UNII: 059QF0KO0R) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) COCOA (UNII: D9108TZ9KG) CENTELLA ASIATICA LEAF (UNII: 6810070TYD) TROPOLONE (UNII: 7L6DL16P1T) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) ISOSTEARIC ACID (UNII: X33R8U0062) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) ISOAMYL LAURATE (UNII: M1SLX00M3M) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHYTATE SODIUM (UNII: 88496G1ERL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-080-01 1 in 1 CARTON 01/01/2024 1 33 mL in 1 BOTTLE; 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 01/01/2024 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753)
