Cay Skin Isle Lip Balm Spf 30

SPL v4

SPL

SPL Set ID d92a17c4-9827-5fb1-e053-2a95a90a9ca1

Route

TOPICAL

Published

Effective Date 2025-01-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (30 mg) Octisalate (50 mg) Homosalate (100 mg)

Inactive Ingredients

Potassium Sorbate Ci 77492 Sodium Benzoate Sheanut Oil Butyloctyl Salicylate Glyceryl Monostearate Erythritol Chondrus Crispus Cetyl Alcohol Ceresin Hydrogenated Polybutene (1300 Mw) Phytosteryl/octyldodecyl Lauroyl Glutamate Methyl Dihydroabietate Trihydroxystearin Water C18-38 Alkyl Hydroxystearoyl Stearate Vinylpyrrolidone/hexadecene Copolymer Vanillin Aloe Vera Leaf Titanium Dioxide Tocopherol Ci 77491 Citric Acid Monohydrate Ci 15850 Ci 77499

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%

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.

Directions

Adults and children over 6 months of age:
Apply liberally 15 minutes before sun exposure.
Reapply: at least every 2 hours or after 40 minutes of swimming or sweating.
Children under 6 months of age: ask a doctor.
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 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-sleeved shirts, pants, hats and sunglasses.

Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun.

Product Packaging

Inactive Ingredients

Cocoa Cabana

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Citric Acid, Methyl Dihydroabietate, Trihydroxystearin, Potassium Sorbate, Sodium Benzoate, Vanillin, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

Coral

Nude Ting

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides)

Irie Rose

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

Bad Gyal Berry

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

Questions Or Comments?

cayskin.com (256) 396-8268

When Using This Product

keep out of eyes. Rinse with water to remove.

Active Ingredients (w/w)

Avobenzone 3%, Homosalate 10%, Octisalate 5%

Product Packaging Coral

Product Packaging Irie Rose

Product Packaging Nude Ting

Stop Use and Consult A Doctor

if skin rash occurs.

Keep Out of Reach of Children.

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

Product Packaging Cocoa Cabana

Product Packaging Bad Gyal Berry

Structured Label Content

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.

Purpose

Sunscreen

Warnings

For external use only.

Directions

Adults and children over 6 months of age:
Apply liberally 15 minutes before sun exposure.
Reapply: at least every 2 hours or after 40 minutes of swimming or sweating.
Children under 6 months of age: ask a doctor.
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 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-sleeved shirts, pants, hats and sunglasses.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Product Packaging

Inactive Ingredients (Inactive ingredients)

Cocoa Cabana

Coral

Nude Ting

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides)

Irie Rose

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

Bad Gyal Berry

Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

Questions Or Comments? (Questions or comments?)

cayskin.com (256) 396-8268

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Active Ingredients (w/w) (Active ingredients (w/w))

Avobenzone 3%, Homosalate 10%, Octisalate 5%

Product Packaging Coral (Product Packaging - Coral)

Product Packaging Irie Rose (Product Packaging - Irie Rose)

Product Packaging Nude Ting (Product Packaging - Nude Ting)

Stop Use and Consult A Doctor (Stop use and consult a doctor)

if skin rash occurs.

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

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

Product Packaging Cocoa Cabana (Product Packaging - Cocoa Cabana)

Product Packaging Bad Gyal Berry (Product Packaging - Bad Gyal Berry)

Advanced Ingredient Data

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Raw Label Data

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{"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.", "Purpose": "Sunscreen", "Warnings": "For external use only.", "Directions": "Adults and children over 6 months of age: Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours or after 40 minutes of swimming or sweating. Children under 6 months of age: ask a doctor. 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 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-sleeved shirts, pants, hats and sunglasses.", "Do not use": "on damaged or broken skin.", "Other information": "Protect this product from excessive heat and direct sun.", "Inactive ingredients": "Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Dihydroabietate, Trihydroxystearin, Erythritol, Aloe Barbadensis Leaf Juice, Water (Aqua), Chondrus Crispus Extract Cocoa Cabana Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Citric Acid, Methyl Dihydroabietate, Trihydroxystearin, Potassium Sorbate, Sodium Benzoate, Vanillin, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake) Coral Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Citric Acid, Methyl Dihydroabietate, Trihydroxystearin, Potassium Sorbate, Sodium Benzoate, Vanillin, CI 77891 (Titanium Dioxide), CI 77491/CI 77492 Nude Ting Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides) Irie Rose Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake) Bad Gyal Berry Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)", "Questions or comments?": "cayskin.com (256) 396-8268", "When using this product": "keep out of eyes. Rinse with water to remove.", "Active ingredients (w/w)": "Avobenzone 3%, Homosalate 10%, Octisalate 5%", "Stop use and consult a doctor": "if skin rash occurs.", "Keep out of reach of children.": "If product is swallowed, get medical help or contact a Poison Control Center right away."}

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Source: dailymed · Ingested: 2026-02-15T12:05:23.005535 · Updated: 2026-03-14T23:07:05.651363