Coretex Sunx 50 Thick

SPL v5

SPL

SPL Set ID f67a6c6c-c314-1c9d-e053-2a95a90a7f1a

Route

TOPICAL

Published

Effective Date 2025-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Homosalate (10 g) Octocrylene (5 g) Octisalate (3 g) Avobenzone

Inactive Ingredients

Phenoxyethanol Propylene Glycol Ethylhexylglycerin Water Theobroma Cacao Whole Sodium Hydroxide C12-20 Alkyl Benzoate Disodium Edta-copper Methylcellulose, Unspecified Acrylates Crosspolymer-6 .alpha.-tocopherol Acetate Peg-6 Sorbitan Oleate Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Medium Density Polyethylene Polysorbate 20

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-09 Until 2025-02-06

Description

Avobenzone...3% Homosalate...10% Octisalate...5% Octocrylene...5%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone...3% Homosalate...10% Octisalate...5% Octocrylene...5%

Uses:

helps prevent sunburn.
higher SPF gives more sunburn protection.
retains SPF after 80 minutes of activity in the water or sweating.
provides high protection against sunburn.

Warnings

For external use only.

Do Not Use

on damaged or broken skin

Questions?

Call: 1-877-684-5774

Directions:

apply liberally 15 minutes before sun exposure.

Reapply:
after 80 minutes of swimming or sweating
after towel drying, swimming, or
at least every 2 hours

Children under 6 months of age: ask a doctor.

65753 602 24

65753 603 01

65753 603 02

65753 603 03

65753 603 04

65753 603 05

65753 603 07

65753 603 09

65753 603 10

65753 603 32

65753 603 33

65753 603 34

65753 603 35

65753 603 39

Other Information:

Protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients:

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...5%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbedensis 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, tocopheryl acetate, water.

When Using This Product

keep out of eyes. Rinse with water to remove

65753 602 22, 23, 26,and 31

65753 603 22, 23, 24, 25, 26

Stop Use and Ask A Doctor If

rash or irritation develops and lasts

Keep Out of Reach of Children

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

Structured Label Content

Uses:

helps prevent sunburn.
higher SPF gives more sunburn protection.
retains SPF after 80 minutes of activity in the water or sweating.
provides high protection against sunburn.

Purpose

Sunscreen

Warnings

For external use only.

Do Not Use (Do not use)

on damaged or broken skin

Questions?

Call: 1-877-684-5774

Directions:

apply liberally 15 minutes before sun exposure.

Reapply:
after 80 minutes of swimming or sweating
after towel drying, swimming, or
at least every 2 hours

Children under 6 months of age: ask a doctor.

65753 602 24 (65753-602-24)

65753 603 01 (65753-603-01)

65753 603 02 (65753-603-02)

65753 603 03 (65753-603-03)

65753 603 04 (65753-603-04)

65753 603 05 (65753-603-05)

65753 603 07 (65753-603-07)

65753 603 09 (65753-603-09)

65753 603 10 (65753-603-10)

65753 603 32 (65753-603-32)

65753 603 33 (65753-603-33)

65753 603 34 (65753-603-34)

65753 603 35 (65753-603-35)

65753 603 39 (65753-603-39)

Other Information:

Protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients:

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...5%

Inactive Ingredients (Inactive ingredients)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

65753 602 22, 23, 26,and 31 (65753-602-22,-23,-26,and -31)

65753 603 22, 23, 24, 25, 26 (65753-603-22,-23,-24,-25,-26)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash or irritation develops and lasts

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

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"PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THEOBROMA CACAO WHOLE", "unii": "EB048G1S9J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-20 ALKYL BENZOATE", "unii": "Y15I6XI14C", "classCode": "IACT", 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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM DENSITY POLYETHYLENE", "unii": "3W404QE89S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", 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Raw Label Data

All Sections (JSON)

{"Uses:": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water or sweating. provides high protection against sunburn.", "Purpose": "Sunscreen Sunscreen Sunscreen Sunscreen", "Warnings": "For external use only.", "Do not use": "on damaged or broken skin", "Questions?": "Call: 1-877-684-5774", "Directions:": "apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating after towel drying, swimming, or 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. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.", "Active Ingredients:": "Avobenzone...3% Homosalate...10% Octisalate...5% Octocrylene...5%", "Inactive ingredients": "acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbedensis 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, tocopheryl acetate, water.", "When using this product": "keep out of eyes. Rinse with water to remove", "Stop use and ask a doctor if": "rash or irritation develops and lasts", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:30.300681 · Updated: 2026-03-14T23:07:26.290118