Label: CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET kit
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NDC Code(s):
65753-108-39,
65753-109-39,
65753-110-37,
65753-400-39, view more65753-514-36
- Packager: CoreTex Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Hand Sanitizer Active Ingredients:
- Hand Sanitizer Purpose
- Hand Sanitizer Uses:
- Hand Sanitizer Warnings
- Hand Sanitizer Directions:
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Hand Sanitizer
Inactive Ingredients:
actinidia chinesis (kiwi) extract, aloe barbadenis leaf juice, aminomethyl propanol, brassica oleracea italica (broccoli) extract, cannabis sativa (hemp) seed extract, carbomer citrullus vulgaris (watermelon) fruit extract, euterpe oleracea fruit extract, fragaria vesca (strawberry) fruit extract, glycerin, helianthus annus (sunfloer) seed oil, hippophae rhamnoides (sea buckthorn) fruit extract, lycium barbarum (goji) extract, myrciaria dubia (camu camu) fruit extract, propanediol, propylene glycol, punica granatum extract, rubus idaeus seed extract, tocopherol acetate (vitamin E acetate), vaccinium angustifolium (blueberry) extract, vaccinium macrocarpon (cranberry) fruit extract, vitis vinifera (grape) seed extra, water
- Hand Sanitizer Other Information:
- SunX 30 Active Ingredients:
- SunX 30 Purpose
- SunX 30 Uses:
- SunX 30 Warnings
- SunX 30 Directions:
- SunX 30 Other Information:
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SunX 30
Inactive Ingredients:
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylexyiglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water
- SunX 30 Questions?
- SunX 50 Lip Balm Active Ingredients:
- SunX 50 Lip Balm Purpose
- SunX 50 Lip Balm Uses:
- SunX 50 Lip Balm Warnings
- SunX 50 Lip Balm Directions:
- SunX 50 Lip Balm Other information:
- SunX 50 Lip Balm Inactive Ingredients:
- Anti-Itch Active Ingredients:
- Anti-Itch Purpose
- Anti-Itch Uses:
- Anti-Itch Warnings
- Anti-Itch Directions:
- Anti-Itch Other Information:
- Anti-Itch Inactive Ingredients:
- Anti-Itch Questions?
- Sting X Active Ingredients:
- Sting X Purpose
- Sting X Use:
- Sting X Warnings
- Sting X Directions:
- Sting X Inactive Ingredients:
- Sting X Other Information:
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Outdoor Professional Kit and Refill Kit Contents
1 ea – Sun X SPF 30 Broad Spectrum Lotion Pouch
1 ea – Sun X SPF 30 Broad Spectrum Multi-Pack Pouch w/Towelette
1 ea – Sun X SPF 30 Lip Balm
2 ea – Bug X 30 Insect Repellent Towelette
2 ea – Ivy X Pre-Contact Barrier Towelette
2 ea – Ivy X Post-Contact Cleanser Towelette
2 ea – Burn X Lite Cooling Gel Pouch
1 ea – Anti-Itch Gel Pouch
1 ea – Sting X Pain Relief Pad
1 ea – Hand Sanitizer Gel Pouch - Professional Outdoor Kit Label
- Hand Sanitizer Package Label
- SunX 30 Label
- SunX 30 Multipack with Towelette Label
- SunX 50 Lip Balm Label
- Anti-Itch Label
- Sting X Label
- Burn X Label 65753
- IVY X Cleanser Label
- IVY X Pre Label
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INGREDIENTS AND APPEARANCE
CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET
coretex professional outdoor skin protection wallet kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65753-514 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-514-36 1 in 1 KIT; Type 0: Not a Combination Product 02/24/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 44 mL Part 2 1 POUCH 7 g Part 3 14809258 APPLICATOR 65753105 mL Part 4 1 POUCH 1 mL Part 5 1 POUCH 1.1 mL Part 6 1 POUCH 3.5 mL Part 1 of 6 CORETEX SUN X SPF 30 NEW
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:65753-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 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 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM HYDROXIDE (UNII: 55X04QC32I) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S) Product Characteristics Color white (Thick White Lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-110-37 44 mL in 1 PACKET; 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 10/01/2023 Part 2 of 6 CORETEX SUN X SPF 30 MULTIPACK NEW
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:65753-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SODIUM HYDROXIDE (UNII: 55X04QC32I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-109-39 7 g 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 10/01/2023 Part 3 of 6 SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM
avobenzone, homosalate, octinoxate, octisalate, petrolatum lipstickProduct Information Item Code (Source) NDC:65753-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 40 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) COCONUT OIL (UNII: Q9L0O73W7L) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MINERAL OIL (UNII: T5L8T28FGP) WHITE WAX (UNII: 7G1J5DA97F) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-108-39 4.44 mL in 1 APPLICATOR; 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 02/24/2023 Part 4 of 6 CORETEX ANTI-ITCH GEL
camphor, diphenhydramine, zinc acetate gelProduct Information Item Code (Source) NDC:65753-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.1 g in 100 mL ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 g in 100 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) METHYLPARABEN (UNII: A2I8C7HI9T) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-400-39 1 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 M017 11/01/2023 Part 5 of 6 STINGX
benzocaine swabProduct Information Item Code (Source) NDC:65753-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1.1 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 M017 11/25/2019 Part 6 of 6 CORETEX ANTIBACTERIAL HAND SANITIZER
sd alcohol liquidProduct Information Item Code (Source) NDC:65753-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) GLYCERIN (UNII: PDC6A3C0OX) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3.5 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 M004 11/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/24/2023 Labeler - CoreTex Products Inc (061944620) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises 017701475 manufacture(65753-400, 65753-350) Establishment Name Address ID/FEI Business Operations CoreTex Products Inc 061944620 pack(65753-514, 65753-200, 65753-108, 65753-110, 65753-109, 65753-350, 65753-400) Establishment Name Address ID/FEI Business Operations Pure Source 080354456 manufacture(65753-109, 65753-110) Establishment Name Address ID/FEI Business Operations Raining Rose 083819404 manufacture(65753-108) Establishment Name Address ID/FEI Business Operations HealthSpecialty 794053863 manufacture(65753-200)