Active ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

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.

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 product is 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 and 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, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

Questions and comments?

Call: 1-877-684-5774

Kit Contents

1-Towelette

65753-109-22-23-31-26

sunxpouch

65753-109-24

109-24

CORETEX SUN X SPF 30 MULTIPACK NEW
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65753-109
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65753-109-22	25 in 1 CONTAINER	01/08/2023
1		7 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:65753-109-23	25 in 1 CONTAINER	01/08/2023
2		7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:65753-109-24	50 in 1 CONTAINER	01/08/2023
3		7 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:65753-109-31	150 in 1 BOX	01/08/2023
4		7 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:65753-109-26	300 in 1 BOX	01/08/2023
5		7 g 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	01/08/2023

Labeler - CoreTex Products (061944620)

Name	Address	ID/FEI	Business Operations
Establishment
CoreTex Products		061944620	manufacture(65753-109)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises		101946028	manufacture(65753-109)

Sun X SPF 30 Thick Multi-Pack New formulation 65753-109