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

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Sun X SPF 30 Thick New formulation
65753-110

Active ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 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 the eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of the reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

Other information

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, tocopherol acetate, water

Questions and comments?

Call: 1-877-684-5774

Principal Display Panel

SunX30thicknew

CORETEX SUN X SPF 30 NEW 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65753-110-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
2NDC:65753-110-3244 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
3NDC:65753-110-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
4NDC:65753-110-3359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
5NDC:65753-110-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
6NDC:65753-110-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
7NDC:65753-110-04177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
8NDC:65753-110-05236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
9NDC:65753-110-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
10NDC:65753-110-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
11NDC:65753-110-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2021
12NDC:65753-110-3744 mL in 1 PACKET; Type 0: Not a Combination Product01/07/2021
13NDC:65753-110-181000 in 1 CARTON01/07/2021
1344 mL in 1 PACKET; Type 0: Not a Combination Product
14NDC:65753-110-2225 in 1 CONTAINER01/07/2021
147 mL in 1 PACKET; Type 0: Not a Combination Product
15NDC:65753-110-2350 in 1 CONTAINER01/07/2021
157 mL in 1 PACKET; Type 0: Not a Combination Product
16NDC:65753-110-2450 in 1 CARTON01/07/2021
167 mL in 1 PACKET; Type 0: Not a Combination Product
17NDC:65753-110-25100 in 1 CARTON01/07/2021
177 mL in 1 PACKET; Type 0: Not a Combination Product
18NDC:65753-110-26300 in 1 BOX01/07/2021
187 mL in 1 PACKET; Type 0: Not a Combination Product
19NDC:65753-110-081 in 1 BOX01/07/2021
19500 mL in 1 BAG; Type 0: Not a Combination Product
20NDC:65753-110-401 in 1 BOX01/07/202111/21/2022
20751 mL in 1 BOTTLE; Type 0: Not a Combination Product
21NDC:65753-110-35751 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/07/2021
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620pack(65753-110)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(65753-110)

Revised: 10/2023
Document Id: 08fb1bbf-f361-29da-e063-6394a90aa397
Set id: 08fb4748-d22d-35af-e063-6394a90a0827
Version: 1
Effective Time: 20231030
 
CoreTex Products Inc