Label: COOLA LIPLUX HYDRATING OIL SPF 30- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 79753-018-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions - Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Apply at least every 2 hours.
Sun Protection Measures - To decrease your risk of cancer and early skin aging. 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. and wear
long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients-Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate
- OTHER SAFETY INFORMATION
- QUESTIONS
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INGREDIENTS AND APPEARANCE
COOLA LIPLUX HYDRATING OIL SPF 30
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10.0 g in 100 mL Inactive Ingredients Ingredient Name Strength ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) CAMELLIA OIL (UNII: T1PE06G0VE) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PUNICA GRANATUM FLOWER (UNII: D9B634V4GP) JOJOBA OIL (UNII: 724GKU717M) SACCHARIN SODIUM (UNII: SB8ZUX40TY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-018-01 1 in 1 CARTON 12/22/2020 1 3.2 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 12/22/2020 Labeler - COOLA LLC (956990290)