Vacation®

Vacation®
SPL v1
SPL
SPL Set ID b595aa53-b5fb-4516-a819-17a70e3eb472
Route
TOPICAL
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Shea Butter Caprylhydroxamic Acid Medium-chain Triglycerides Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Caprylyl Caprylate/caprate Caprylyl Glyceryl Ether Cucumber Dicaprylyl Carbonate Diheptyl Succinate Galactoarabinan Glycerin Helianthus Annuus Flowering Top Magnesium Sulfate, Unspecified Form Methyl Dihydroabietate Niacin Rice Bran Polyglyceryl-2 Oleate Polyglyceryl-2 Stearate Propanediol Rosemary .alpha.-tocopherol Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-19

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 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

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

Zinc Oxide 20%

Inactive Ingredients

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Caprylate/Caprate, Caprylyl Glyceryl Ether, Cucumis Sativus (Cucumber) Fruit Extract, Dicaprylyl Carbonate, Diheptyl Succinate, Galactoarabinan, Glycerin, Helianthus Annuus (Sunflower) Extract, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Oryza Sativa (Rice) Bran Extract, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyhydroxystearic Acid, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (Vitamin E), Triethoxycaprylylsilane, Water

Principal Display Panel 100 Ml Tube Label

Vacation®

Mineral Lotion

BROAD SPECTRUM SPF 30 SUNSCREEN

By the "Legendary" Vacation® of Miami—

"Luxury-Grade" Non-Nano Zinc Formula

Sunscreen for "Long Days by the Pool"

Water-Resistant (80 Minutes)

"Leisure-Enhancing"

SPF 30

3.4 FL OZ / 100 ML


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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

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)

Zinc Oxide 20%

Inactive Ingredients (Inactive ingredients)

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Caprylate/Caprate, Caprylyl Glyceryl Ether, Cucumis Sativus (Cucumber) Fruit Extract, Dicaprylyl Carbonate, Diheptyl Succinate, Galactoarabinan, Glycerin, Helianthus Annuus (Sunflower) Extract, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Oryza Sativa (Rice) Bran Extract, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyhydroxystearic Acid, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (Vitamin E), Triethoxycaprylylsilane, Water

Principal Display Panel 100 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 100 ML Tube Label)

Vacation®

Mineral Lotion

BROAD SPECTRUM SPF 30 SUNSCREEN

By the "Legendary" Vacation® of Miami—

"Luxury-Grade" Non-Nano Zinc Formula

Sunscreen for "Long Days by the Pool"

Water-Resistant (80 Minutes)

"Leisure-Enhancing"

SPF 30

3.4 FL OZ / 100 ML


Advanced Ingredient Data


Raw Label Data

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