NDC | 31190-210-20, 31190-210-30 |
Set ID | 71004651-90fd-48d7-ba10-82b4a0283bdb |
Category | HUMAN OTC DRUG LABEL |
Packager | Shanghai Kejing Cleaning Products Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPF 30 Sunscreen Lotion
- Active Ingredients
- Purpose
- Uses
- Warnings
- Keep out of Reach of Children
- Directions
- Inactive Ingredients
- Other information
- Questions or Comment ?
- Representative Label
-
INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30
octinoxate, octisalate, oxybenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31190-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 20 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MYRISTYL PROPIONATE (UNII: P59053E7NJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) EDETATE DISODIUM (UNII: 7FLD91C86K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DMDM HYDANTOIN (UNII: BYR0546TOW) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31190-210-20 20 mL in 1 BOTTLE 2 NDC:31190-210-30 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/13/2014 Labeler - Shanghai Kejing Cleaning Products Co., Ltd (526877847) Establishment Name Address ID/FEI Business Operations Shanghai Kejing Cleaning Products Co., Ltd 526877847 manufacture(31190-210)