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

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

Product Packaging

isle lip balm

Product Packaging - Cocoa Cabana

Product Packaging - Coral

Product Packaging - Nude Ting

Product Packaging - Irie Rose

Product Packaging - Bad Gyal Berry

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2023

Labeler - Cay Skin, Inc. (118574309)

Name	Address	ID/FEI	Business Operations
Establishment
Atlantis Laboratories, Inc.		194673984	manufacture(82657-011, 82657-014, 82657-012, 82657-010, 82657-001, 82657-013)

Cay Skin Isle Lip Balm SPF 30