Label: PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 604)- zinc oxide lotion
- NDC Code(s): 83100-1761-1, 83100-1761-2
- Packager: B.A.I. Biosciences 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 February 17, 2023
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- pavise Lip Defense tinted hydrating oil (hue 604)
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INGREDIENTS AND APPEARANCE
PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 604)
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83100-1761 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) DIAMOND (UNII: 6GRV67N0U2) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ISOSTEARIC ACID (UNII: X33R8U0062) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) PHENYLPROPANOL (UNII: 0F897O3O4M) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC) Product Characteristics Color red Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83100-1761-2 1 in 1 CARTON 02/17/2023 1 NDC:83100-1761-1 5 mL in 1 BOTTLE; 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 02/17/2023 Labeler - B.A.I. Biosciences INC. (083612207) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(83100-1761) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 pack(83100-1761) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(83100-1761) , manufacture(83100-1761)
