NDC | 69015-100-01 |
Set ID | fe06a496-9627-49f7-820d-7d3eb7d30b79 |
Category | HUMAN OTC DRUG LABEL |
Packager | Racinne (Hong Kong) Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
AQUA, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, CAPRYLIC/ CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, CETEARYL OLIVATE, CETEARYL ALCOHOL, SORBITAN OLIVATE, DIMETHICONE, PEG-100 STEARATE, POLY-SORBATE 60, NELUMBO NUCIFERA CALLUS CULTURE EXTRACT, XANTHAN GUM, PHENOXYETHANOL, TOCOPHERYL ACETATE, FRAGRANCE, SODIUM BENZOATE, POLYACRYLATE-13, SORBITAN STEARATE, DISODIUM EDTA, ROYAL JELLY EXTRACT, PEARL EXTRACT, GLYCERIN, POLYISOBUTENE, POTASSIUM SORBATE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, BHT, PROPYLENE GLYCOL, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EQUISETUM ARVENSE EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SORBITAN ISOSTEARATE, POLYSORBATE 20, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, VERONICA OFFICINALIS EXTRACT, PRIMULA VERIS EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT, ALCHEMILLA VULGARIS EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, SODIUM HYALURONATE, FRUCTAN, CAPRYLYL GLYCOL, ACETYL TYROSINE, 1,2- HEXANEDIOL, PAEONIA SUFFRUTICOSA ROOT EXTRACT, PUERARIA LOBATA ROOT EXTRACT, ETHYLHEXYLGLYCERIN - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ULTIMATE AQUA BLANC PROTECTIVE
octinoxate, octisalate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69015-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 mg in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 mg in 50 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69015-100-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2014 Labeler - Racinne (Hong Kong) Limited (663588145) Registrant - Racinne (Hong Kong) Limited (663588145) Establishment Name Address ID/FEI Business Operations Racinne (Hong Kong) Limited 663588145 manufacture(69015-100)