Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (5%), Octisalate (3%), Octocrylene (10%)

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 ask a doctor if rash occurs

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses children under 6 months of age: ask a physician.

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyloctyl Salicylate, C18-38 Alkyl Hydroxystearoyl Stearate, Canola Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Wax, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stevia Rebaudiana Leaf Extract, Sunflower Seed Oil Glycerides, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Tocopheryl Acetate

Distributed by Vacation Inc.

PRINCIPAL DISPLAY PANEL - Kit Carton

5 TUBE COLLECTER'S SET

VACATION®
LIP TRIPS:

Desserts

SPF 30 SUNSCREEN LIP BALM

BROAD SPECTRUM SPF 30 | VEGAN & CRUELTY FREE
WATER RESISTANT (80 MINUTES)

5 - 0.15 OZ (4.25 G) BALMS
TOTAL NET WT. 0.75 OZ (21.25 G)

VACATION LIP TRIPS DESSERTS
avobenzone, homosalate, octisalate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80641-201

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80641-201-01	1 in 1 CARTON	01/15/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	4.25 g
Part 2	1 TUBE	4.25 g
Part 3	1 TUBE	4.25 g
Part 4	1 TUBE	4.25 g
Part 5	1 TUBE	4.25 g

Part 1 of 5

VACATION LIP TRIPS DESSERTS PINEAPPLE UPSIDE DOWN CAKE
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)
Canola Oil (UNII: 331KBJ17RK)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Soybean Oil (UNII: 241ATL177A)
Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
Olive Oil (UNII: 6UYK2W1W1E)
Castor Oil (UNII: D5340Y2I9G)
Rosemary (UNII: IJ67X351P9)
Jojoba Oil (UNII: 724GKU717M)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Part 2 of 5

VACATION LIP TRIPS DESSERTS BOMBE ALASKA
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)
Canola Oil (UNII: 331KBJ17RK)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Soybean Oil (UNII: 241ATL177A)
Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
Olive Oil (UNII: 6UYK2W1W1E)
Castor Oil (UNII: D5340Y2I9G)
Rosemary (UNII: IJ67X351P9)
Jojoba Oil (UNII: 724GKU717M)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Part 3 of 5

VACATION LIP TRIPS DESSERTS AFTER DINNER MINT
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)
Canola Oil (UNII: 331KBJ17RK)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Soybean Oil (UNII: 241ATL177A)
Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
Olive Oil (UNII: 6UYK2W1W1E)
Castor Oil (UNII: D5340Y2I9G)
Rosemary (UNII: IJ67X351P9)
Jojoba Oil (UNII: 724GKU717M)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Part 4 of 5

VACATION LIP TRIPS DESSERTS STRAWBERRY JELLO
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)
Canola Oil (UNII: 331KBJ17RK)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Soybean Oil (UNII: 241ATL177A)
Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
Olive Oil (UNII: 6UYK2W1W1E)
Castor Oil (UNII: D5340Y2I9G)
Rosemary (UNII: IJ67X351P9)
Jojoba Oil (UNII: 724GKU717M)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Part 5 of 5

VACATION LIP TRIPS DESSERTS BANANAS FOSTER
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
C18-38 Alkyl Hydroxystearoyl Stearate (UNII: WW4FVB2PEM)
Canola Oil (UNII: 331KBJ17RK)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Soybean Oil (UNII: 241ATL177A)
Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
Olive Oil (UNII: 6UYK2W1W1E)
Castor Oil (UNII: D5340Y2I9G)
Rosemary (UNII: IJ67X351P9)
Jojoba Oil (UNII: 724GKU717M)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/15/2022

Labeler - Vacation Inc. (117644631)

Name	Address	ID/FEI	Business Operations
Establishment
Raining Rose		083819404	MANUFACTURE(80641-201)

Vacation® Lip Trips Desserts