Sun X SPF 30 Thick New formulation 65753-106

CoreTex Sun X SPF 30 New by

Drug Labeling and Warnings

CoreTex Sun X SPF 30 New by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CORETEX SUN X SPF 30 NEW- avobenzone, homosalate, octisalate, octocrylene lotion 
CoreTex Products Inc

----------

Sun X SPF 30 Thick New formulation
65753-106

Active ingredients

Avobenzone 3%

Homosalate 7.5%

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 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, 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

Principal Display Panel
65753-106-01

106-01

65753-106-32

106-32

65753-106-02

106-02

65753-106-33

106-33

65753-106-03

106-03

65753-106-34

106-34

65753-106-04

106-04

65753-106-05

106-05

65753-106-07

106-07

65753-106-35

106-35

65753-106-09

106-09

65753-106-10

106-10

65753-106-22,-23,-24,-25,-26

106-22

CORETEX SUN X SPF 30 NEW 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-106-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
2NDC: 65753-106-3244 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
3NDC: 65753-106-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
4NDC: 65753-106-3359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
5NDC: 65753-106-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
6NDC: 65753-106-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
7NDC: 65753-106-04177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
8NDC: 65753-106-05236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
9NDC: 65753-106-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
10NDC: 65753-106-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
11NDC: 65753-106-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/202110/30/2023
12NDC: 65753-106-3744 mL in 1 PACKET; Type 0: Not a Combination Product01/07/202110/30/2023
13NDC: 65753-106-181000 in 1 CARTON01/07/202110/30/2023
1344 mL in 1 PACKET; Type 0: Not a Combination Product
14NDC: 65753-106-2225 in 1 CONTAINER01/07/202110/30/2023
147 mL in 1 PACKET; Type 0: Not a Combination Product
15NDC: 65753-106-2350 in 1 CONTAINER01/07/202110/30/2023
157 mL in 1 PACKET; Type 0: Not a Combination Product
16NDC: 65753-106-2450 in 1 CARTON01/07/202110/30/2023
167 mL in 1 PACKET; Type 0: Not a Combination Product
17NDC: 65753-106-25100 in 1 CARTON01/07/202110/30/2023
177 mL in 1 PACKET; Type 0: Not a Combination Product
18NDC: 65753-106-26300 in 1 BOX01/07/202110/30/2023
187 mL in 1 PACKET; Type 0: Not a Combination Product
19NDC: 65753-106-081 in 1 BOX01/07/202110/30/2023
19500 mL in 1 BAG; Type 0: Not a Combination Product
20NDC: 65753-106-401 in 1 BOX01/07/202111/21/2022
20751 mL in 1 BOTTLE; Type 0: Not a Combination Product
21NDC: 65753-106-35751 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/202210/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/07/202110/30/2023
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620pack(65753-106)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(65753-106)

Revised: 1/2024
Document Id: 08fb9a0b-aea3-3ed0-e063-6394a90a4746
Set id: b857f370-541b-0d4c-e053-2a95a90a1c98
Version: 5
Effective Time: 20240105
 
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.