Label: SIIMUNANA BIO SUN STICK- ethylhexyl salicylate, menthol cream, augmented
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Contains inactivated NDC Code(s)
NDC Code(s): 84565-001-01 - Packager: Guangzhou Simunana Biotechnology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 22, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
SIIMUNANA BIO SUN STICK
ethylhexyl salicylate, menthol cream, augmentedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84565-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) YELLOW WAX (UNII: 2ZA36H0S2V) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 2-ETHYLHEXYL ISOHEXADECANOATE (UNII: E1RR6O4O9S) CERESIN (UNII: Q1LS2UJO3A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) D&C RED NO. 6 (UNII: 481744AI4O) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOCETANE (UNII: 8LP0677305) DIMETHICONE (UNII: 92RU3N3Y1O) OCTOCRYLENE (UNII: 5A68WGF6WM) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84565-001-01 20 g in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/22/2024 Labeler - Guangzhou Simunana Biotechnology Co., Ltd. (451134769) Establishment Name Address ID/FEI Business Operations Guangzhou Simunana Biotechnology Co., Ltd. 451134769 manufacture(84565-001)

