CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET kit

CoreTex Professional Outdoor Skin Protection Wallet by

Drug Labeling and Warnings

CoreTex Professional Outdoor Skin Protection Wallet by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Cosmetic Enterprises, Pure Source, Raining Rose, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hand Sanitizer Active Ingredients:

SD Alcohol 40-B 62.5%

Hand Sanitizer Purpose

Antimicrobial

Hand Sanitizer Uses:

Hand Sanitizer to help reduce bacteria on the skin.

Hand Sanitizer Warnings

Flammable. Keep away from heat or flame.

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.If swallowed, get help or contact a Poison Control Center right away.

Hand Sanitizer Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.

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:

Store below 110 oF (43 o), Read the Safety Data Sheet for this Product. You may obtain an SDS from our website: www.coretexproducts.com or Call: 1-877-684-5774

SunX 30 Active Ingredients:

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 5.0%

SunX 30 Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

SunX 30 Uses:

• helps prevent sunburn.
• higher SPF gives more sunburn protection.
• retains SPF after 80 minutes of activity in the water or sweating.
• provides high protection against sunburn.

SunX 30 Warnings

For external use only

SunX 30
Do Not Use

• on damaged or broken skin

When using this product

• keep out of the eyes
• rinse with water to remove

Stop use and ask a doctor if

• rash or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

SunX 30 Directions:

• apply liberally and evenly 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• after towel drying, swimming, or
• at least every 2 hours
• children under 6 months of age: Ask a doctor

SunX 30 Other Information:

• protect this product from excessive heat or direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

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?

Call: 1-877-684-5774

SunX 50 Lip Balm Active Ingredients:

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate...7.5%

Octisalate…5.0%

Petrolatum...40.0%

SunX 50 Lip Balm Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Skin Protectant

SunX 50 Lip Balm Uses:

Helps protect against sunburn and chapped lips.

SunX 50 Lip Balm Warnings

Sun Alert:Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Do not use

Do not useon damaged or broken skin.

Stop use and ask a doctor if

• rash occurs

When using this product

• keep out of eyes. Rinse to remove.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SunX 50 Lip Balm Directions:

• Apply liberally before sun exposure and as needed
• Children under 6 months of age: Ask a doctor before use.

SunX 50 Lip Balm Other information:

protect the product in this container from excessive heat and direct sun.

SunX 50 Lip Balm Inactive Ingredients:

C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol.

Anti-Itch Active Ingredients:

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Anti-Itch Purpose

Extrenal analgesic

Antihistamine

Skin protectant

Anti-Itch Uses:

• For the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac.
• dries the oozing and weeping of poison ivy, poison oak, poison sumac.

Anti-Itch Warnings

For external use only

Do Not Use

• on chicken pox, blisters or on extensive areas of the skin
• with any drugs containing diphenhydramine while using this product.

When using this product

• keep out of eyes.

Stop use and ask a doctor if

• conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed get medical help or contact Poison Control center right away.

Anti-Itch Directions:

• Adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed bu a doctor.

Anti-Itch Other Information:

• protect this product from excessive heat and direct sun.

Anti-Itch Inactive Ingredients:

citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

Anti-Itch Questions?

Call: 1-877-684-5774

Sting X Active Ingredients:

Benzocaine 6%

Sting X Purpose

Topical Analgesic

Sting X Use:

For temporary pain relief from insect bites and stings

Sting X Warnings

For external use only

Do not use

• in or near eyes
• over large areas of the body
• over raw or blistered areas

Stop use and ask a doctor if

• conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed get medical help or contact Poison Control center right away.

Sting X Directions:

Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older.

Sting X Inactive Ingredients:

SD alcohol 40, water (aqua), glycerin, allantoin

Sting X Other Information:

Made in USA for CoreTex Products, Inc.

Bakersfield, CA 93308

www.CoreTexProducts.com (877)684-5774

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

INGREDIENTS AND APPEARANCE

CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET 
coretex professional outdoor skin protection wallet kit

Product 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 lotion

Product 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 lotion

Product 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 lipstick

Product 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 gel

Product 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 swab

Product 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 liquid

Product Information
Item Code (Source)	NDC: 65753-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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	01/01/2024

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, 65753-201, 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)