VACATION X AZ LEMON TEA LIP BALM SPF 30- avobenzone, homosalate, octisalate, and octocrylene lipstick VACATION X AZ MUCHO MANGO LIP BALM SPF 30- avobenzone, homosalate, octisalate, and octocrylene lipstick VACATION X AZ GREEN TEA LIP BALM SPF 30- avobenzone, homosalate, octisalate, and octocrylene lipstick

Vacation X AZ Green Tea Lip Balm SPF 30 by

Drug Labeling and Warnings

Vacation X AZ Green Tea Lip Balm SPF 30 by is a Otc medication manufactured, distributed, or labeled by Vacation INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Vacation X AZ Lemon Tea Lip Balm SPF 30

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. If swallowed, 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: ask a doctor.

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

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by Vacation Inc.
936 SW 1st Ave #888
Miami, FL 33130

SPL UNCLASSIFIED SECTION

Vacation X AZ Mucho Mango Lip Balm SPF 30

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. If swallowed, 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: ask a doctor.

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

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distr. by Vacation Inc.
936 SW 1st Ave #888
Miami, FL 33130

SPL UNCLASSIFIED SECTION

Vacation X AZ Green Tea Lip Balm SPF 30

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. If swallowed, 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: ask a doctor.

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

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by Vacation Inc.
936 SW 1st Ave #888
Miami, FL 33130

PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - LEMON TEA

SPF
30

AriZona®

Broad Spectrum SPF 30

Iced tea

LIP BALM SUNSCREEN
with LEMON TEA FLAVOR

WATER RESISTANT (80 MINUTES)

NET WT. 0.15 OZ / 4.25 G

PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - Mucho Mango

AriZona®

BROAD SPECTRUM
SPF 30 SUNSCREEN

Mucho Mango®
Flavored Lip Balm

WATER RESISTANT (80 MINUTES)

NET WT. 0.15 OZ / 4.25 G

PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - Green Tea and HONEY

AriZona®

SPF
30

BROAD
SPECTRUM
SPF30
SUNSCREEN

Green Tea
and HONEY
Flavored LIP BALM

WATER RESISTANT
(80 MINUTES)

NET WT. 0.15 OZ / 4.25 G

INGREDIENTS AND APPEARANCE

VACATION X AZ LEMON TEA LIP BALM SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-105
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
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	30 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-105-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2022

VACATION X AZ MUCHO MANGO LIP BALM SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-106
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
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	30 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-106-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2022

VACATION X AZ GREEN TEA LIP BALM SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-107
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
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	30 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-107-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2022

Labeler - Vacation INC. (117644631)