NDC | 70611-001-01 |
Set ID | 2fd24cc7-5007-1117-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Yoyo Lip Gloss Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP USE
- ASK DOCTOR
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive Ingredients
INGREDIENTS/INGREDIENT: Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Ceresin, Beeswax, Microcrystalline Wax, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea Butter), Stevioside, Flavor, Silica Dimethyl Silylate, Diisostearyl Malate, Bis-diglycery, Polyacyladipate-2, Tocopheryl Acetate, MAY CONTAIN/PEUT CONTENIR: Titanium Dioxide, FD&C Blue No.1, D&C Yellow No.10, D&C Red No.28, Iron Oxides, Mica.
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TROPICAL PINEAPPLE JUMBO LIP BALM
oxybenzone, octinoxate, homosalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70611-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 10 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 10 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) FERROUS OXIDE (UNII: G7036X8B5H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PODOPHYLLUM RESIN (UNII: 16902YVY2B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ETHYLHEXYL PALMITATE (UNII: 2865993309) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) YELLOW WAX (UNII: 2ZA36H0S2V) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SHEA BUTTER (UNII: K49155WL9Y) STEVIOSIDE (UNII: 0YON5MXJ9P) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) CERESIN (UNII: Q1LS2UJO3A) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70611-001-01 4.2 g in 1 TUBE; Type 0: Not a Combination Product 04/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/06/2016 Labeler - Yoyo Lip Gloss Inc. (828881792)