Vacation®

Vacation®
SPL v1
SPL
SPL Set ID 69022828-8226-4977-a2ca-ad8e16793a59
Route
TOPICAL
Published
Effective Date 2022-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.03 g) Homosalate (0.05 g) Octisalate (0.1 g) Octocrylene
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate C18-38 Alkyl Hydroxystearoyl Stearate Canola Oil Coconut Oil Candelilla Wax Soybean Oil Helianthus Annuus Seed Wax Olive Oil Castor Oil Rosemary Jojoba Oil Stevia Rebaudiuna Leaf Cocoa Butter .alpha.-tocopherol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-15
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
Section 50570-1
  • 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
Warnings

For external use only

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
Active Ingredients

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

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

Principal Display Panel 4.25 G Tube Label Bombe Alaska

VACATION®

LIP TRIPS:

Desserts

BOMBE

ALASKA

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Bananas Foster

VACATION®

LIP TRIPS:

Desserts

BANANAS

FOSTER

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label After Dinner Mint

VACATION®

LIP TRIPS:

Desserts

AFTER DINNER

MINT

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Strawberry Jello Salad

VACATION®

LIP TRIPS:

Desserts

STRAWBERRY

JELLO SALAD

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Pineapple Upside Down Cake

VACATION®

LIP TRIPS:

Desserts

PINEAPPLE

UPSIDE-DOWN CAKE

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
  • 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
Purpose

Sunscreen

Warnings

For external use only

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 (Other information)
  • Protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

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

Inactive Ingredients (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

Principal Display Panel 4.25 G Tube Label Bombe Alaska (PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - BOMBE ALASKA)

VACATION®

LIP TRIPS:

Desserts

BOMBE

ALASKA

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Bananas Foster (PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - BANANAS FOSTER)

VACATION®

LIP TRIPS:

Desserts

BANANAS

FOSTER

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label After Dinner Mint (PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - AFTER DINNER MINT)

VACATION®

LIP TRIPS:

Desserts

AFTER DINNER

MINT

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Strawberry Jello Salad (PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - STRAWBERRY JELLO SALAD)

VACATION®

LIP TRIPS:

Desserts

STRAWBERRY

JELLO SALAD

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Principal Display Panel 4.25 G Tube Label Pineapple Upside Down Cake (PRINCIPAL DISPLAY PANEL - 4.25 G Tube Label - PINEAPPLE UPSIDE-DOWN CAKE)

VACATION®

LIP TRIPS:

Desserts

PINEAPPLE

UPSIDE-DOWN CAKE

BROAD SPECTRUM SPF 30

LIP BALM SUNSCREEN

WATER RESISTANT (80 MINUTES)

Cruelty-Free & Vegan

Distributed by Vacation Inc. © 2021

936 SW 1st Ave #888

Miami, FL 33130

NET WT. 0.15 OZ / 4.25 G

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:59.027475 · Updated: 2026-03-14T23:00:14.731892