Sun X SPF 30 Thick Multi-Pack New formulation

CoreTex Sun X SPF 30 Multipack New by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sun X SPF 30 Thick Multi-Pack New formulation

Active ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweatingchildren under 6 months of age: Ask a doctor
  • immediately after towel drying
  • at least every 2 hours

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:

• limit time in the sun, especially from 10:00 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.
• children under 6 months: Ask a doctor

Other information

• Protect this product from excessive heat or direct 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, tocopherol acetate, water

Questions and comments?

Call: 1-877-684-5774

Kit Contents

1-Towelette

Principal Display Panel

CORETEX SUN X SPF 30 MULTIPACK NEW 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-107-22	25 in 1 CONTAINER	01/07/2021	01/08/2023
1		7 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 65753-107-23	25 in 1 CONTAINER	01/07/2021	01/08/2023
2		7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 65753-107-24	50 in 1 CONTAINER	01/07/2021	01/08/2023
3		7 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 65753-107-31	150 in 1 BOX	01/07/2021	01/08/2023
4		7 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 65753-107-26	300 in 1 BOX	01/07/2021	01/08/2023
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 not final	part352	01/07/2021	01/08/2023

Labeler - CoreTex Products (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products		061944620	manufacture(65753-107)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(65753-107)

Revised: 2/2023

Document Id: f57b915d-06c5-f128-e053-2a95a90a2027

34390-5

Set id: b8aa62a7-6345-4d17-e053-2995a90a28e7

Version: 2

Effective Time: 20230224