Vacation X Az Green Tea Lip Balm Spf 30 Lipstick
FDA Label NDC 80641-107

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vacation Inc. for the product Vacation X Az Green Tea Lip Balm Spf 30 (NDC 80641-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Vacation X AZ Lemon Tea Lip Balm SPF 30

Drug Facts

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

Vacation X AZ Mucho Mango Lip Balm SPF 30

Drug Facts

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

Vacation X AZ Green Tea Lip Balm SPF 30

Drug Facts

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

Active Ingredients

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

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

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

Purpose

Sunscreen

Sunscreen

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
    • 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
      • 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
    • For external use only
      • For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin
    • Do not use on damaged or broken skin
      • Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs
    • Stop use and ask a doctor if rash occurs
      • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
      • 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.
        • 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.
              • 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

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

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.

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

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

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)

Principal Display Panel (4.25 G Tube Label)

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)

Principal Display Panel (4.25 G Tube Label)

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

Principal Display Panel (4.25 G Tube Label)

Principal Display Panel (4.25 G Tube Label)

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