CORTEX SUNX 50 THICK- avobenzone, homosalate, octisalate, octocrylene lotion

CorTex SunX 50 Thick by

Drug Labeling and Warnings

CorTex SunX 50 Thick by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...5%

Purpose

Sunscreen

Sunscreen

Sunscreen

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 and 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 barbedensis 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?

Call: 1-877-684-5774

65753-603-09

65753-602-24

65753-602-22,-23,-26,and -31

65753-603-03

65753-603-22,-23,-24,-25,-26

65753-603-10

65753-603-35

65753-603-02

65753-603-01

65753-603-33

65753-603-07

65753-603-05

65753-603-04

65753-603-34

65753-603-32

65753-603-39

INGREDIENTS AND APPEARANCE

CORTEX SUNX 50 THICK 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-602
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-602-22	25 in 1 CONTAINER	03/09/2023
1		7 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 65753-602-23	25 in 1 CONTAINER	03/09/2023
2		7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 65753-602-24	50 in 1 CONTAINER	03/09/2023
3		7 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 65753-602-26	150 in 1 CARTON	03/09/2023
4		7 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 65753-602-31	300 in 1 CARTON	03/09/2023
5		7 g 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	03/09/2023

CORTEX SUNX 50 THICK 
avobenzone, homosalate, octisalate, octocrylene lotion

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	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

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-603-22	25 in 1 CONTAINER	03/09/2023
1	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 65753-603-23	25 in 1 CONTAINER	03/09/2023	02/06/2025
2	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 65753-603-24	50 in 1 CONTAINER	03/09/2023
3	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 65753-603-26	150 in 1 CARTON	03/09/2023	02/06/2025
4	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 65753-603-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
6	NDC: 65753-603-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
7	NDC: 65753-603-35	762 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
8	NDC: 65753-603-09	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
9	NDC: 65753-603-10	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
10	NDC: 65753-603-25	100 in 1 CONTAINER	03/09/2023
10	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 65753-603-03	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
12	NDC: 65753-603-32	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
13	NDC: 65753-603-33	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
14	NDC: 65753-603-04	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
15	NDC: 65753-603-05	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
16	NDC: 65753-603-07	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
17	NDC: 65753-603-34	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2023
18	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product	03/09/2023
19	NDC: 65753-603-43	50 in 1 CONTAINER	03/09/2023
19	NDC: 65753-603-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
20	NDC: 65753-603-46	300 in 1 CARTON	03/09/2023
20	NDC: 65753-603-39	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	03/09/2023

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-602, 65753-603)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(65753-603, 65753-602)