Label: COOLA MINERAL LIPLUX LIP BALM SPF 30 SUMMER CRUSH- zinc oxide stick
- NDC Code(s): 79753-057-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 2, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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
Acacia Decurrens Flower Wax, Butyrospermum Parkii (ORGANIC Shea Butter), C18-38 Alkyl Hydroxystearoyl
Stearate, Caesalpinia Sappan Bark Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax,
Flavor, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Castor Oil,
Iron Oxides, Jojoba Esters, Mica, Octyldodecyl Oleate, Octyldodecyl PCA, Olea Europaea (ORGANIC Olive) Fruit Oil, Persea
Gratissima (ORGANIC Avocado) Oil, Polyglycerin-3, Polyhydroxystearic Acid, Red Lake 7, Rosmarinus Officinalis (ORGANIC
Rosemary) Leaf Extract, Schinziophyton Rautanenii Kernel Oil (ORGANIC), Silica, Stevia Rebaudiana Extract, Theobroma Cacao
(ORGANIC Cocoa) Seed Butter, Theobroma Grandiflorum Seed Butter (ORGANIC), Tin Oxide, Triethoxycaprylsilane - OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA MINERAL LIPLUX LIP BALM SPF 30 SUMMER CRUSH
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-057 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 SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) STANNIC OXIDE (UNII: KM7N50LOS6) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) OLIVE OIL (UNII: 6UYK2W1W1E) D&C RED NO. 7 (UNII: ECW0LZ41X8) 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) CAESALPINIA SAPPAN BARK (UNII: R6995U1QSX) MICA (UNII: V8A1AW0880) 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-057-01 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)
