CORETEX SUN X 50 SUNSCREEN FACE STICK- avobenzone, homosalate, octisalate, octocrylene stick

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, Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...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 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 liberally (or 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 this risk, regularly use 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 a.m. -2 p.m.
• wear long-sleaved shirts, pants, hats and sunglasses.
• reapply:
• after 80 minutes of swimming or sweating.
• immediately after towel drying.
• at least every 2 hours.
• Children under 6 months of age: Ask a doctor

Other information

• protect this product from excessive heat and direct sun.

Inactive ingredients

aloe barbadensis leaf extract, beeswax, butyrospermum parkii (shea) butter, CI2-15 alkyl benzoate, capryilc/capric triglyceride, ethylhexylglycerin, helianthus annuus (sunflower) seed oil, olea europaea (olive) fruit oil, ozokerite, phenoxyethanol, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vp/hexadecene copolymer, zinc oxide

Questions?

Call: 1-877-684-5774

-604-01

INGREDIENTS AND APPEARANCE

CORETEX SUN X 50 SUNSCREEN FACE STICK 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ZINC OXIDE (UNII: SOI2LOH54Z)
PARAFFIN (UNII: I9O0E3H2ZE)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
OLIVE OIL (UNII: 6UYK2W1W1E)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
WHITE WAX (UNII: 7G1J5DA97F)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-604-01	14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product	10/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/05/2024

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-604)