Label: COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED- avobenzone, octisalate, octocrylene stick
- NDC Code(s): 79753-019-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
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), Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Tapioca Starch (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Polyhydroxystearic Acid, Titanium Dioxide, Maltodextrin, Flavor, Bisabolol (ORGANIC), Ipomoea Batatas Tuber Extract, Acacia Senegal Gum, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Iron Oxides, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Citric Acid, Rosa Canina Fruit Extract (ORGANIC), Raphanus Sativus (Radish) Root Extract, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Tocopherol (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil, Linoleic Acid, Phospholipids, Phytosterols, Aloe Barbadensis Leaf Extract
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED
avobenzone, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-019 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) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) SUNFLOWER OIL (UNII: 3W1JG795YI) COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559) SOY STEROL (UNII: PL360EPO9J) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) ROSEMARY (UNII: IJ67X351P9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SAFFLOWER OIL (UNII: 65UEH262IS) RASPBERRY SEED OIL (UNII: 9S8867952A) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) SWEET POTATO (UNII: M9WGG9Z9GK) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, TAPIOCA (UNII: 24SC3U704I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ACACIA (UNII: 5C5403N26O) RADISH (UNII: EM5RP35463) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-019-01 1 in 1 CARTON 07/01/2021 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 07/01/2021 Labeler - COOLA, LLC (956990290)