CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL kit

CoreTex Professional Outdoor Skin Protection Wallet Refill by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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:

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

Sting X Other Information:

Made in USA for CoreTex Products, Inc.

Erwin, TN 37650

www.CoreTexProducts.com (877)684-5774

Professional Outdoor Kit Label

SunX 30 Label 65753-106

Sting X

IVY X Cleanser Label

Bug X 30

Ivy X Solution

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-513

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-513-35	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	1.1 mL

Part 1 of 2

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)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.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 2

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

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(65753-350)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-513, 65753-110, 65753-350)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(65753-110)