Label: KINESYS SPF 30 SOLID SUNSCREEN- octinoxate, octisalate, oxybenzone, and titanium dioxide stick
- NDC Code(s): 61481-0045-1, 61481-0045-2, 61481-0045-3
- Packager: Wilc Healthcare 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 September 19, 2019
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- Active Ingredients
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label
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INGREDIENTS AND APPEARANCE
KINESYS SPF 30 SOLID SUNSCREEN
octinoxate, octisalate, oxybenzone, and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-0045 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 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X) CANDELILLA WAX (UNII: WL0328HX19) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) TRIBEHENIN (UNII: 8OC9U7TQZ0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61481-0045-1 7.3 g in 1 TUBE; Type 0: Not a Combination Product 06/20/2012 2 NDC:61481-0045-2 4 g in 1 TUBE; Type 0: Not a Combination Product 06/20/2012 3 NDC:61481-0045-3 1 in 1 PACKAGE 06/20/2012 3 NDC:61481-0045-1 7.3 g in 1 TUBE; 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 part352 06/20/2012 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-0045)