CAY SKIN ISLE LIP BALM SPF 30 CORAL- avobenzone, homosalate, octisalate cream CAY SKIN ISLE LIP BALM SPF 30 BAD GYAL BERRY- avobenzone, homosalate, octisalate cream CAY SKIN ISLE LIP BALM SPF 30 NUDE TING- avobenzone, homosalate, octisalate cream CAY SKIN ISLE LIP BALM SPF 30 COCOA CABANA- avobenzone, homosalate, octisalate cream CAY SKIN ISLE LIP BALM SPF 30- avobenzone, homosalate, octisalate cream CAY SKIN ISLE LIP BALM SPF 30 IRIE ROSE- avobenzone, homosalate, octisalate cream

Cay Skin Isle Lip Balm SPF 30 by

Drug Labeling and Warnings

Cay Skin Isle Lip Balm SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cay Skin, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (w/w)

Avobenzone 3%, Homosalate 10%, Octisalate 5%

Purpose

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 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.

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.

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

Product Packaging

Product Packaging - Cocoa Cabana

Product Packaging - Coral

Product Packaging - Nude Ting

Product Packaging - Irie Rose

Product Packaging - Bad Gyal Berry

INGREDIENTS AND APPEARANCE

CAY SKIN ISLE LIP BALM SPF 30 CORAL 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 77492 (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
VANILLIN (UNII: CHI530446X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-011-01	1 in 1 CARTON	01/01/2025
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2025

CAY SKIN ISLE LIP BALM SPF 30 BAD GYAL BERRY 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 15850 (UNII: 481744AI4O)
CI 77492 (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CI 77499 (UNII: XM0M87F357)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-014-01	1 in 1 CARTON	01/01/2023
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

CAY SKIN ISLE LIP BALM SPF 30 NUDE TING 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 77492 (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CI 77499 (UNII: XM0M87F357)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-012-01	1 in 1 CARTON	01/01/2024
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

CAY SKIN ISLE LIP BALM SPF 30 COCOA CABANA 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CI 77499 (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 77492 (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
VANILLIN (UNII: CHI530446X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CI 15850 (UNII: 481744AI4O)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-010-01	1 in 1 CARTON	09/13/2024
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/13/2024

CAY SKIN ISLE LIP BALM SPF 30 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
VANILLIN (UNII: CHI530446X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-001-01	1 in 1 CARTON	03/29/2022
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/29/2022

CAY SKIN ISLE LIP BALM SPF 30 IRIE ROSE 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CI 15850 (UNII: 481744AI4O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 77492 (UNII: EX438O2MRT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEANUT OIL (UNII: O88E196QRF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ERYTHRITOL (UNII: RA96B954X6)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERESIN (UNII: Q1LS2UJO3A)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CI 77499 (UNII: XM0M87F357)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-013-01	1 in 1 CARTON	01/01/2023
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

Labeler - Cay Skin, Inc. (118574309)