Label: CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET kit
- NDC Code(s): 65753-100-37, 65753-504-36
- 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 November 21, 2022
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
-
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 Keep out of reach of children
-
SunX 30
Directions
- apply liberally and evenly 15 minutes before sun exposure
- Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and after sun protection measures including:
- limit time in the sun, especially from 10:00 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
- SunX 30 Other Information
-
SunX 30
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water
- SunX 30 Questions?
- SunX 30 Lip Balm Active Ingredients
- SunX 30 Lip Balm Purpose
- SunX 30 Lip Balm Uses
- SunX 30 Lip Balm Warnings
- SunX 30 Lip Balm Keep out of reach of children
- SunX 30 Lip Balm Directions
-
SunX 30 Lip Balm
Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures:
- limit time in the sun, especially from 10a.m.-2p.m.
- wear long sleeved shirts, pants, hats, and sunglasses.
- SunX 30 Lip Balm Inactive Ingredients
- SunX 30Lip Balm Other information
- Anti-Itch Active Ingredients
- Anti-Itch Purpose
- Anti-Itch Uses
- Anti-Itch Warnings
- Anti-Itch Keep out of reach of children
- 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 Stop use and ask a doctor if
- Sting X Keep out of reach of children.
- 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
- Professional Outdoorkit Refill
- Hand Sanitizer Package Label
- SunX 30 Label
- SunX 30 Multipack with Towelette Label
- SunX 30 Lip Balm Label
- Anti-Itch Label
- Sting X Label
-
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:65753-504 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65753-504-36 1 in 1 KIT; Type 0: Not a Combination Product 11/27/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 44 mL Part 2 1 POUCH 7 g Part 3 1480926 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
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotionProduct Information Item Code (Source) NDC:65753-100 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 GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) CHAMOMILE (UNII: FGL3685T2X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLPARABEN (UNII: 14255EXE39) PEG-100 STEARATE (UNII: YD01N1999R) NASTURTIUM OFFICINALE (UNII: YH89GMV676) COMFREY LEAF (UNII: DG4F8T839X) 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:65753-100-37 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 not final part352 01/25/2013 Part 2 of 6 SUN X MULTI-PACK SPF 30 THICK
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotionProduct Information Item Code (Source) NDC:65753-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLPARABEN (UNII: 14255EXE39) PEG-100 STEARATE (UNII: YD01N1999R) NASTURTIUM OFFICINALE (UNII: YH89GMV676) COMFREY LEAF (UNII: DG4F8T839X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE SODIUM (UNII: MP1J8420LU) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) CHAMOMILE (UNII: FGL3685T2X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 not final part352 01/01/2017 Part 3 of 6 SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstickProduct Information Item Code (Source) NDC:65753-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 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 Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) COCONUT OIL (UNII: Q9L0O73W7L) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 44.4 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 not final part352 01/01/2017 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 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 not final part348 11/25/2019 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 not final part348 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 EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP) HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y) PROPYLENE GLYCOL 1-BUTYRATE (UNII: PUV901J64H) VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW) ACTINIDIA CHINENSIS WHOLE (UNII: 8HTD3WU8LH) BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53) CANNABIS SATIVA SEED (UNII: QE567Z26NG) PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E) FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) VITIS VINIFERA SEED (UNII: C34U15ICXA) CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) RUBUS IDAEUS SEED (UNII: M3CL7US2ZG) GLYCERIN (UNII: PDC6A3C0OX) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) 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 not final part333E 11/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/27/2019 Labeler - CoreTex Products Inc (061944620) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises 017701475 manufacture(65753-350, 65753-400) Establishment Name Address ID/FEI Business Operations CoreTex Products Inc 061944620 pack(65753-504, 65753-200, 65753-105, 65753-102, 65753-100, 65753-350, 65753-400) Establishment Name Address ID/FEI Business Operations Pure Source 080354456 manufacture(65753-100, 65753-102) Establishment Name Address ID/FEI Business Operations Raining Rose 083819404 manufacture(65753-105) Establishment Name Address ID/FEI Business Operations HealthSpecialty 794053863 manufacture(65753-200)