CORETEX SUN X 50- avobenzone, homosalate, octisalate, octocrylene lotion

CoreTex Sun X 50 by

Drug Labeling and Warnings

CoreTex Sun X 50 by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone

Homosalate

Octisalate

Octocrylene

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other 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 eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children

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

Directions

apply generously and evenly 15 minutes before sun exposure

Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or ;higher and other sun protection measures including:

• limit time in the sun, especially from 10 am to 2 pm
• wear long-sleeved shirt, pants, hat and sunglasses

reapply

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every two hours

Children under 6 months of age: Ask a doctor.

Other information

• protect the product from excessive heat and direct sun

Inactive ingredients

benzoic acid, caprylyl methicone, cetyl PEG/PPG-10-1 dimethicone, dicaprylyl ether, edetate disodium, ethylhexylglycerin,glycereth-2 cocoate, stearyl/octyldodecyl citrate crosspolymer, phenoxyethanol, propylene glycol, sodium chloride, water

Questions?

Call 1-877-684-5774

Principal Display Panel

INGREDIENTS AND APPEARANCE

CORETEX SUN X 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.4 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white (White Lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-600-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
2	NDC: 65753-600-32	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
3	NDC: 65753-600-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
4	NDC: 65753-600-33	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
5	NDC: 65753-600-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
6	NDC: 65753-600-34	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
7	NDC: 65753-600-04	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
8	NDC: 65753-600-05	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
9	NDC: 65753-600-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
10	NDC: 65753-600-08	473 mL in 1 BAG; Type 0: Not a Combination Product	08/16/2019
11	NDC: 65753-600-09	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
12	NDC: 65753-600-10	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2019
13	NDC: 65753-600-39	7 mL in 1 POUCH; Type 0: Not a Combination Product	08/16/2019
14	NDC: 65753-600-22	175 in 1 CONTAINER	08/16/2019
14	NDC: 65753-600-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
15	NDC: 65753-600-23	350 in 1 CONTAINER	08/16/2019
15	NDC: 65753-600-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
16	NDC: 65753-600-24	350 in 1 CONTAINER	08/16/2019
16	NDC: 65753-600-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
17	NDC: 65753-600-25	700 in 1 CONTAINER	08/16/2019
17	NDC: 65753-600-39	7 mL in 1 POUCH; Type 0: Not a Combination Product
18	NDC: 65753-600-26	2100 in 1 CARTON	08/16/2019
18	NDC: 65753-600-39	7 mL 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	08/16/2019

Labeler - CoreTex Products (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products		061944620	label(65753-600)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(65753-600)