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

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]

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-110
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 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

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: 65753-110-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
2	NDC: 65753-110-32	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
3	NDC: 65753-110-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
4	NDC: 65753-110-33	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
5	NDC: 65753-110-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
6	NDC: 65753-110-34	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
7	NDC: 65753-110-04	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
8	NDC: 65753-110-05	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
9	NDC: 65753-110-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
10	NDC: 65753-110-09	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
11	NDC: 65753-110-10	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2021
12	NDC: 65753-110-37	44 mL in 1 PACKET; Type 0: Not a Combination Product	01/07/2021
13	NDC: 65753-110-18	1000 in 1 CARTON	01/07/2021
13		44 mL in 1 PACKET; Type 0: Not a Combination Product
14	NDC: 65753-110-22	25 in 1 CONTAINER	01/07/2021
14		7 mL in 1 PACKET; Type 0: Not a Combination Product
15	NDC: 65753-110-23	50 in 1 CONTAINER	01/07/2021
15		7 mL in 1 PACKET; Type 0: Not a Combination Product
16	NDC: 65753-110-24	50 in 1 CARTON	01/07/2021
16		7 mL in 1 PACKET; Type 0: Not a Combination Product
17	NDC: 65753-110-25	100 in 1 CARTON	01/07/2021
17		7 mL in 1 PACKET; Type 0: Not a Combination Product
18	NDC: 65753-110-26	300 in 1 BOX	01/07/2021
18		7 mL in 1 PACKET; Type 0: Not a Combination Product
19	NDC: 65753-110-08	1 in 1 BOX	01/07/2021
19		500 mL in 1 BAG; Type 0: Not a Combination Product
20	NDC: 65753-110-40	1 in 1 BOX	01/07/2021	11/21/2022
20		751 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC: 65753-110-35	751 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/07/2021

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-110)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(65753-110)