Label: MEDICATED FADE CREME WITH SUNSCREEN- hydroquinone and octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 16708-002-01 - Packager: Bluefield Associates, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 26, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses:
- Warnings
- Do Not use on
- Keep out of the reach of children.
- Questions or Comments?
- Directions
-
Inactive Ingredients
Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).
-
INGREDIENTS AND APPEARANCE
MEDICATED FADE CREME WITH SUNSCREEN
hydroquinone and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16708-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 0.02 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.025 g in 1 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) EDETATE TRISODIUM (UNII: 420IP921MB) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) STEARIC ACID (UNII: 4ELV7Z65AP) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16708-002-01 1 in 1 BOX 1 113.5 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 10/26/2015 Labeler - Bluefield Associates, Inc. (626594667) Establishment Name Address ID/FEI Business Operations Bluefield Associates, Inc. 626594667 manufacture(16708-002)