NDC | 12027-101-26 |
Set ID | 8ce635b9-4704-4f89-93f2-ed4679842491 |
Category | HUMAN OTC DRUG LABEL |
Packager | Markwins Beauty Products, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or skin aging.
For external use only.
Do not use on damaged or broken skin
When using this product keep out of eyes.
Rinse with water to remove.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients: Pentaerythrityl Tetraisostearate, Bis-Diglyceryl Polyacyladipate-2, Ethylhexyl Isononanoate, Propylheptyl Caprylate, Ozokerite, Tridecyl Trimellitate, Mineral Oil/Huile minérale, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Diisostearyl Malate, Polyethylene, Euphorbia Cerifera (Candelilla) Wax/Cire de candelilla, Beeswax/Cire d’abeille, Ricinus Communis (Castor) Seed Oil, Caprylyl Glycol, Hydrogenated Styrene/Isoprene Copolymer, Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Sorbic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Laminaria Ochroleuca Extract, BHT, Fragrance/Parfum
(MAY CONTAIN/PEUT CONTENIR): Blue 1 Lake/CI 42090, Red 7 Lake/CI 15850, Red 28 Lake/CI 45410, Titanium Dioxide/CI 77891, Yellow 6 Lake/CI 15985, Yellow 10 Lake/CI 47005, Zinc Oxide/CI 77947) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WET N WILD JUICY LIP BALM
octinoxate octocrylene oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12027-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.0 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) CERESIN (UNII: Q1LS2UJO3A) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) MINERAL OIL (UNII: T5L8T28FGP) TRIDECYL STEARATE (UNII: A8OE252M6L) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CASTOR OIL (UNII: D5340Y2I9G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) AVOCADO OIL (UNII: 6VNO72PFC1) SORBIC ACID (UNII: X045WJ989B) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 28 (UNII: 767IP0Y5NH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12027-101-26 7.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/01/2011 Labeler - Markwins Beauty Products, Inc (135407760) Establishment Name Address ID/FEI Business Operations Markwins International Corp. 544845621 manufacture