Label: REFRESHING WATER HYDRATION STICK SPF 50- avobenzone octisalate homosalate octocrylene stick
- NDC Code(s): 79753-035-01
- 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 January 25, 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: ●after swimming or sweating ● immediately afte
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
Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)
- OTHER SAFETY INFORMATION
- QUESTIONS
- COOLA Label
-
INGREDIENTS AND APPEARANCE
REFRESHING WATER HYDRATION STICK SPF 50
avobenzone octisalate homosalate octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.15 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEARATE (UNII: QU7E2XA9TG) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) POLYGLYCERYL-10 CAPRYLATE (UNII: YS396CQX5C) POLYGLYCERYL-10 CAPRATE (UNII: TL8V5BW2HC) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN OLIVATE (UNII: MDL271E3GR) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) CORALLINA OFFICINALIS (UNII: 4004498D06) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) TROPOLONE (UNII: 7L6DL16P1T) EGGPLANT (UNII: W5K7RAS4VK) COCOA (UNII: D9108TZ9KG) ALOE VERA FLOWER (UNII: 575DY8C1ER) COCONUT WATER (UNII: 267F5Y81NT) JOJOBA OIL (UNII: 724GKU717M) TURMERIC (UNII: 856YO1Z64F) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) HOLY BASIL LEAF (UNII: SCJ765569P) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) HYALURONIC ACID (UNII: S270N0TRQY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-035-01 1 in 1 CARTON 01/16/2023 1 22.0 g in 1 CANISTER; 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 01/16/2023 Labeler - COOLA LLC (956990290)
