Label: LIPLUX SPF 30 LIP BALM- classic stick
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-012-01 - Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 19, 2020
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- Active Ingredients
- Uses
- Warnings
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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 wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, expecially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, paints, hats, and sunglasses. Children under 6 months: ask a doctor.
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Inactive ingredients
Aloe Barbadensis Leaf Extract, Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Linoleic Acid, Persea Gratissima (Avocado) Oil (Organic), Phospholipids, Phytosterols, Polyhydroxstearic Acid, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Simmondsia Chinensis (Jojoba) Seed OIl (ORGANIC), Stevia Rebaudiana Extract, Tetrahexyldecyl Ascorbate, Theobroma Grandiflorum Seed Butter (ORGANIC), Tocopherol (ORGANIC)
- Other Information
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- Primary and secondary package labels
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INGREDIENTS AND APPEARANCE
LIPLUX SPF 30 LIP BALM
classic stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength LINOLEIC ACID (UNII: 9KJL21T0QJ) SAFFLOWER OIL (UNII: 65UEH262IS) ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559) COCONUT OIL (UNII: Q9L0O73W7L) BEHENYL BEHENATE (UNII: K8NU647RJ0) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) CANDELILLA WAX (UNII: WL0328HX19) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) CARNAUBA WAX (UNII: R12CBM0EIZ) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) AVOCADO OIL (UNII: 6VNO72PFC1) ALOE VERA LEAF (UNII: ZY81Z83H0X) REBAUDIOSIDE A (UNII: B3FUD0528F) JOJOBA OIL (UNII: 724GKU717M) CASTOR OIL (UNII: D5340Y2I9G) ROSEMARY (UNII: IJ67X351P9) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) LEVOMENOL (UNII: 24WE03BX2T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) RASPBERRY SEED OIL (UNII: 9S8867952A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-012-01 4.2 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2020 Labeler - COOLA LLC (956990290)
