Label: COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL- avobenzone, octisalate, octocrylene stick
- NDC Code(s): 79753-067-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 22, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Apply liberally 15 minutes before sun exposure & again after 80 minutes of 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENT
Cocos Nucifera (Coconut) Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Polyhydroxystearic Acid, Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Canina Fruit Extract (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Caprylic/Capric Triglyceride, Linoleic Acid, Phytosterols, Phospholipids, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Extract, Stevia Rebaudiana Extract, Flavor
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL
avobenzone, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-067 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.6 g in 100 g Inactive Ingredients Ingredient Name Strength LINOLEIC ACID (UNII: 9KJL21T0QJ) ALOE VERA LEAF (UNII: ZY81Z83H0X) BEHENYL BEHENATE (UNII: K8NU647RJ0) CARNAUBA WAX (UNII: R12CBM0EIZ) CANDELILLA WAX (UNII: WL0328HX19) CASTOR OIL (UNII: D5340Y2I9G) LEVOMENOL (UNII: 24WE03BX2T) AVOCADO OIL (UNII: 6VNO72PFC1) SUNFLOWER OIL (UNII: 3W1JG795YI) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559) RASPBERRY SEED OIL (UNII: 9S8867952A) SOY STEROL (UNII: PL360EPO9J) ROSEMARY (UNII: IJ67X351P9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SAFFLOWER OIL (UNII: 65UEH262IS) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-067-01 1 in 1 CARTON 02/01/2021 1 4.2 g 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 02/01/2021 Labeler - COOLA, LLC (956990290)
