Label: LIP BALM- zinc oxide lip balm ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 62932-184-25 - Packager: Private Label Select Ltd CO
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 23, 2018
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- X3EM Tropicsport Mineral Lip Balm SPF15
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INGREDIENTS AND APPEARANCE
LIP BALM
zinc oxide lip balm ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-184 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) COCOA BUTTER (UNII: 512OYT1CRR) SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2) SUNFLOWER OIL (UNII: 3W1JG795YI) RASPBERRY SEED OIL (UNII: 9S8867952A) TOCOPHEROL (UNII: R0ZB2556P8) TAMANU OIL (UNII: JT3LVK84A1) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SHEA BUTTER (UNII: K49155WL9Y) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) YELLOW WAX (UNII: 2ZA36H0S2V) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62932-184-25 4 g in 1 TUBE; Type 0: Not a Combination Product 11/23/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/23/2018 Labeler - Private Label Select Ltd CO (005415463) Registrant - Private Label Select Ltd CO (005415463)
