Active ingredients

Avobenzone...3%

Homosalate...10%

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 eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops or lasts

Keep out of 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 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, ethylexylglycerin, hydroxypropyl methylcellulose phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

Questions?

Call 1-877-684-5774

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600-34

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600-22-23-26-39

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CORETEX SUN X 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65753-603
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65753-603-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
2	NDC:65753-603-32	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
3	NDC:65753-603-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
4	NDC:65753-603-33	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
5	NDC:65753-603-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
6	NDC:65753-603-34	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
7	NDC:65753-603-04	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
8	NDC:65753-603-05	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
9	NDC:65753-603-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
10	NDC:65753-603-09	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
11	NDC:65753-603-10	3788 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2023
12	NDC:65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product	01/03/2023
13	NDC:65753-603-22	25 in 1 CONTAINER	01/03/2023
13	NDC:65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
14	NDC:65753-603-23	25 in 1 CONTAINER	01/03/2023
14	NDC:65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
15	NDC:65753-603-24	50 in 1 CONTAINER	01/03/2023
15	NDC:65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
16	NDC:65753-603-25	100 in 1 CONTAINER	01/03/2023
16	NDC:65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
17	NDC:65753-603-26	300 in 1 CARTON	01/03/2023
17	NDC:65753-603-39	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	01/03/2023

Labeler - CoreTex Products Inc (061944620)

Name	Address	ID/FEI	Business Operations
Establishment
CoreTex Products Inc		061944620	pack(65753-603)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises		101946028	manufacture(65753-603)

Sun X 50 65753-603