CORTEX SUNX 50 THICK- avobenzone, homosalate, octisalate, octocrylene lotion 
CoreTex Products Inc

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CoreTex SunX 50 Thick Multipack
65753-602

Active Ingredients:

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

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:

Other Information:

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

65753-602-24

602-24

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

602

CORTEX SUNX 50 THICK 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-602-2225 in 1 CONTAINER03/09/2023
17 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:65753-602-2325 in 1 CONTAINER03/09/2023
27 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:65753-602-2450 in 1 CONTAINER03/09/2023
37 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:65753-602-26150 in 1 CARTON03/09/2023
47 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:65753-602-31300 in 1 CARTON03/09/2023
57 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/09/2023
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620pack(65753-602)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(65753-602)

Revised: 10/2023
Document Id: 071317c9-19a3-71a7-e063-6394a90a58f2
Set id: f67a6c6c-c314-1c9d-e053-2a95a90a7f1a
Version: 2
Effective Time: 20231006
 
CoreTex Products Inc