Active ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

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

suns-bugxfr

SunX SPF 30 label

sunxlotion pouch

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65753-511

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65753-511-24	1 in 1 KIT; Type 0: Not a Combination Product	10/11/2023

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
PEG-100 STEARATE (UNII: YD01N1999R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65753-101-10	7 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	10/11/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/11/2023

Labeler - CoreTex Products Inc (061944620)

Name	Address	ID/FEI	Business Operations
Establishment
CoreTex Products Inc		061944620	pack(65753-101, 65753-511)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source		080354456	manufacture(65753-101)

SunX SPF 30/BugX Wallmount 65753-511