Label: COOLA BARE REPUBLIC MINERAL BODY GEL-LOTION SPF 30- zinc oxide 18.2% lotion
- NDC Code(s): 79753-042-01
- 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
● 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
Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*,
Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride,
Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa
(Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*,
Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*,
Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower)
Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower
Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum
(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate
Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11,
Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract,
Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis
Vinifera (Grape) Seed Oil, Water, Xanthan Gum
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
-
COOLA Label
SPF
30
BARE
REPUBLIC
MINERAL
Sunscreen
Non-Nano Zinc Oxide
Gel-Lotion
Sheer, Ultra-Light Hydration
Broad Spectrum SPF 30
Water Resistant (40 Minutes)
4.0 FL OZ / 118 mL
*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & CoolSan Diego, CA 92010.
WWW.GOBAREOUTSIDE.COM
res
-
INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC MINERAL BODY GEL-LOTION SPF 30
zinc oxide 18.2% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-042 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 BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ALOE VERA FLOWER (UNII: 575DY8C1ER) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-IONONE (UNII: I9V075M61R) SHEA BUTTER (UNII: K49155WL9Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) CORALLINA OFFICINALIS (UNII: 4004498D06) TURMERIC (UNII: 856YO1Z64F) CARROT SEED OIL (UNII: 595AO13F11) DECANAL (UNII: 31Z90Q7KQJ) .DELTA.-DODECALACTONE (UNII: 33DIC582TL) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) DIMETHICONE (UNII: 92RU3N3Y1O) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) ETHYL FERULATE (UNII: 5B8915UELW) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SUNFLOWER OIL (UNII: 3W1JG795YI) 3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) HEXYL ACETATE (UNII: 7U7KU3MWT0) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) METHYLPROPANEDIOL (UNII: N8F53B3R4R) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) HOLY BASIL LEAF (UNII: SCJ765569P) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) RASPBERRY SEED OIL (UNII: 9S8867952A) EGGPLANT (UNII: W5K7RAS4VK) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITYL LAURATE (UNII: 23XPH3M9LR) TRIDECANE (UNII: A3LZF0L939) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) UNDECANE (UNII: JV0QT00NUE) GRAPE SEED OIL (UNII: 930MLC8XGG) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-042-01 118 mL in 1 TUBE; Type 0: Not a Combination Product 03/02/2020 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)