NDC | 65582-100-04 |
Set ID | f43e76cc-a0c0-434a-a28b-3a0e7b4b3adc |
Category | HUMAN OTC DRUG LABEL |
Packager | International Cosmeceuticals, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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- ACTIVE INGREDIENT
- WARNINGS
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DOSAGE & ADMINISTRATION
DIRECTIONS: For sun protection apply evenly in all exposed areas of scalp after shampooing and rinsing, prior to going outdoors. Reapply every 80 minutes after sweating, prolonged swimming or towel drying. For hair conditioning apply to fingertips and work evenly into hair after shampooing and rinsing.
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INACTIVE INGREDIENT
OTHER INGREDIENTS: Water (aqua), Cetearyl Alcohol, Cetyl Esters, Propylene Glycol, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Cyclomethicone, Cocoa Butter, Cetyl Alcohol, Green Tea Extract, Tocopherol Acetate (Vitamin-E), Hydrolyzed Silk Proteins, Sodium Lauryl Sulfate, Sunflower Oil, Ethylene Glycol Monostearate, Petrolatum, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUINTESSENCE Q-SUNSHADE LEAVE IN HAIR CONDITIONER AND SCALP PROTECTANT SPF 30
octinoxate, oxybenzone, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65582-100 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 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURETH-7 (UNII: Z95S6G8201) CYCLOMETHICONE (UNII: NMQ347994Z) COCOA (UNII: D9108TZ9KG) CETYL ALCOHOL (UNII: 936JST6JCN) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUNFLOWER OIL (UNII: 3W1JG795YI) GLYCOL STEARATE (UNII: 0324G66D0E) PETROLATUM (UNII: 4T6H12BN9U) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65582-100-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/10/2011 Labeler - International Cosmeceuticals, Inc (858902195)