Label: COOLA MINERAL LIPLUX LIP BALM SPF 30 FIRECRACKER- titanium dioxide, zinc oxide stick
- NDC Code(s): 79753-054-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 22, 2024
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- Official Label (Printer Friendly)
- 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), Olea Europaea (Olive) Fruit Oil (ORGANIC), Copernicia Cerifera
(Carnauba) Wax (ORGANIC), Persea Gratissima (Avocado) Oil (ORGANIC), Jojoba Esters, Octyldodecyl Oleate, Butyrospermum
Parkii (Shea) Butter (ORGANIC), Schinziophyton Rautanenii Kernel Oil (ORGANIC), Flavor, Theobroma Cacao (Cocoa) Seed Butter
(ORGANIC), Hydrogenated Castor Oil, Theobroma Grandiflorum Seed Butter (ORGANIC), Octyldodecyl PCA, Helianthus Annuus
(Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC),
Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Stevia
Rebaudiana Extract, Silica, Iron Oxides, Triethoxycaprylylsilane, Red 7 Lake, Red 7, Red 33 Lake - OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA MINERAL LIPLUX LIP BALM SPF 30 FIRECRACKER
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-054 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.6 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g in 100 g Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C RED NO. 7 (UNII: ECW0LZ41X8) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) OCTYLDODECYL PCA (UNII: E25TY46YTD) FERRIC OXIDE RED (UNII: 1K09F3G675) COCONUT OIL (UNII: Q9L0O73W7L) CARNAUBA WAX (UNII: R12CBM0EIZ) AVOCADO OIL (UNII: 6VNO72PFC1) COCOA BUTTER (UNII: 512OYT1CRR) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ROSEMARY (UNII: IJ67X351P9) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SUNFLOWER OIL (UNII: 3W1JG795YI) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-054-01 1 in 1 CARTON 02/01/2019 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 02/01/2019 Labeler - COOLA, LLC (956990290)
