Label: COOLA BARE REPUBLIC MINERAL FACE GEL-LOTION SPF 30- zinc oxide 18.2% lotion
- NDC Code(s): 79753-043-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
● Shake well. 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 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
Water, Caprylic/Capric Triglyceride, Dimethicone, Propylheptyl
Caprylate, Undecane, Methyl Dihydroabietate,
Polyhydroxystearic Acid, Polymethylsilsesquioxane, Tridecane,
Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis
Flower Extract, Aloe Barbadensis Leaf Juice, Butyrospermum
Parkii (Shea) Butter, Olive Oil Polyclyceryl-6 Esters, Melia
Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,
Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant)
Fruit Extract, Curcuma Longa (Turmeric) Root Extract,
Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum
Santcum Leaf Extract, Juniperus Virginiana Oil, Sorbitan
Stearate, Glyceryl Stearate SE, Polyacrylate Crosspolymer-6,
Xanthan Gum, Acrylates Copolymer, Citric Acid,
Methlpropanediol, Polysilicone-11, Caprylyl Glycol, Glycerin,
Sorbityl Laurate, Plyquaternium-80, Corallina Officinalis
Extract, Ethyl Ferulate, Triethoxycaprylylsilane, Lauryl
Glucoside, Didecyldimonium Chloride, Triethyl Citrate, Hexyl
Acetate, Gamma-Nonalactone, Gamma-Octalactone,
Gamma-Undecalactone, Alpha-Ionone, 3-Hexenol, Dimethyl
Heptenal, Decanal - OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- COOLA Label
-
INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC MINERAL FACE GEL-LOTION SPF 30
zinc oxide 18.2% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18.2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) UNDECANE (UNII: JV0QT00NUE) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TRIDECANE (UNII: A3LZF0L939) CUCUMBER (UNII: YY7C30VXJT) ALOE VERA FLOWER (UNII: 575DY8C1ER) ALOE VERA LEAF (UNII: ZY81Z83H0X) SHEA BUTTER (UNII: K49155WL9Y) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) EGGPLANT (UNII: W5K7RAS4VK) TURMERIC (UNII: 856YO1Z64F) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) HOLY BASIL LEAF (UNII: SCJ765569P) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) XANTHAN GUM (UNII: TTV12P4NEE) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPROPANEDIOL (UNII: N8F53B3R4R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) SORBITYL LAURATE (UNII: 23XPH3M9LR) CORALLINA OFFICINALIS (UNII: 4004498D06) ETHYL FERULATE (UNII: 5B8915UELW) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) HEXYL ACETATE (UNII: 7U7KU3MWT0) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) .ALPHA.-IONONE (UNII: I9V075M61R) 3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) DECANAL (UNII: 31Z90Q7KQJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-043-01 1 in 1 CARTON 03/02/2020 1 50 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 Drug M020 03/02/2020 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753) Establishment Name Address ID/FEI Business Operations Bentley Laboratories, LLC 068351753 manufacture(79753-043)
