SUNX SPF 30/BUGX WALLMOUNT kit

SunX SPF 30/BugX Wallmount by

Drug Labeling and Warnings

SunX SPF 30/BugX Wallmount by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

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

Warnings

For external use only.

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 the reach of children

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

Directions

• apply liberally 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

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.

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

Questions?

Call: 1-877-684-5774

SunX/BugX Kit Contents

50 count- SunX SPF 30, BugX 30

Principal Display Panel

SunX SPF 30 label

INGREDIENTS AND APPEARANCE

SUNX SPF 30/BUGX WALLMOUNT 
sunx spf 30/bugx wallmount kit

Product 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 liquid

Product 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)