Label: IM DERMA RELIEF SUNSTICK- octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0010-1 - Packager: Normalest Co., Ltd.
- 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 December 5, 2019
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INGREDIENTS AND APPEARANCE
IM DERMA RELIEF SUNSTICK
octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.2 g in 15 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.675 g in 15 g Inactive Ingredients Ingredient Name Strength HYALURONIC ACID (UNII: S270N0TRQY) CENTELLA ASIATICA (UNII: 7M867G6T1U) DIMETHICONE (UNII: 92RU3N3Y1O) PARAFFIN (UNII: I9O0E3H2ZE) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) CANDELILLA WAX (UNII: WL0328HX19) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) BEMOTRIZINOL (UNII: PWZ1720CBH) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ADENOSINE (UNII: K72T3FS567) MADECASSOSIDE (UNII: CQ2F5O6YIY) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Product Characteristics Color Score Shape ROUND Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72284-0010-1 1 in 1 BOX 12/05/2019 1 15 g in 1 CONTAINER; 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 12/05/2019 Labeler - Normalest Co., Ltd. (694812877) Registrant - Normalest Co., Ltd. (694812877) Establishment Name Address ID/FEI Business Operations Normalest Co., Ltd. 694812877 manufacture(72284-0010)
