Label: SUNX SPF 30/BUGX WALLMOUNT kit
- NDC Code(s): 65753-101-10, 65753-510-24
- Packager: CoreTex Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 11, 2023
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- Active ingredients
- Purpose
- Uses
- Warnings
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- Other information
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Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, soritan oleate, theobroma cacao (cocoa) seed butter, tocopherol, tocopheryl acetate, water
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- SunX/BugX Kit Contents
- Principal Display Panel
- SunX SPF 30 label
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INGREDIENTS AND APPEARANCE
SUNX SPF 30/BUGX WALLMOUNT
sunx spf 30/bugx wallmount kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65753-510 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-510-24 1 in 1 KIT; Type 0: Not a Combination Product 10/11/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 50 POUCH 350 mL Part 1 of 1 CORETEX SUN X SPF 30 THIN
avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquidProduct Information Item Code (Source) NDC:65753-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL 1-CAPRYLATE (UNII: TL885HYH94) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEG-100 STEARATE (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-101-10 7 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/11/2023 Labeler - CoreTex Products Inc (061944620) Establishment Name Address ID/FEI Business Operations CoreTex Products Inc 061944620 pack(65753-101, 65753-510) Establishment Name Address ID/FEI Business Operations Pure Source 080354456 manufacture(65753-101)