NDC | 53950-7007-1 |
Set ID | 447135e8-5d2a-4d28-b629-b2d52e2f2c59 |
Category | HUMAN OTC DRUG LABEL |
Packager | Robanda International, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, Stearic Acid, Glyceryl Stearate, Cetyl Alcohol, Dimethyl Capramide, PEG-100 Stearate, Triethanolamine, Phyllanthus Embilica (Fruit) Extract, Hydroxylated Soy Lethicin, Carbomer, Retinyl Acetate, Retinol, Tetrasodium EDTA, Tocopherol Acetate, Tocopherol, Squalane, Butyrospermum Parkii (Shea Butter), Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyl Dimethyltaurate Copolymer, Ethylhexylglycerin, Polysorbate 60, Titanium Dioxide, Yellow 5 (CI 19140), Red 40 (CI 16035)
Robanda International, Inc.
San Diego, CA, 92110, U.S.A.
Edgware, Middx, HA8 9TA, U.K.
P: (800) 783.9969
P: (619) 276.7660
F: (619) 276.7661
www.robanda.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROBANDA ANTI-AGING HAND
avobenzone, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53950-7007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 mg in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) PEG-100 STEARATE (UNII: YD01N1999R) TROLAMINE (UNII: 9O3K93S3TK) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) VITAMIN A ACETATE (UNII: 3LE3D9D6OY) RETINOL (UNII: G2SH0XKK91) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) SQUALANE (UNII: GW89575KF9) SHEANUT OIL (UNII: O88E196QRF) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53950-7007-1 90 mL in 1 TUBE; Type 0: Not a Combination Product 11/02/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2012 Labeler - Robanda International, Inc. (048214287)