medichoice moisturizing lip balm spf15

medichoice moisturizing lip balm spf15
SPL v3
SPL
SPL Set ID 00327815-28f0-4198-bca7-c8ae768ff416
Route
topical
Published
Effective Date 2023-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) octinoxate (65 mg) octisalate (50 mg) octocrylene (15 mg)
Inactive Ingredients
petrolatum mineral oil paraffin ceresin coconut oil tocopherol soybean oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-12-22

Purpose

Sunscreen

Description

Avobenzone 3.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%


Medication Information

Warnings
  • For external use only
Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor 

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

  • limit time in the sun, especially from 10a.m.-2p.m.
  • wear long sleeved shirts, pants hats, and sunglasses.
Other Information

Protect this product from excessive heat and direct sun.

Description

Avobenzone 3.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients:

Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs
Package Labeling:39892 0940 1

Package Labeling:39892 0940 2

Package Labeling:39892 0940 3

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings
  • For external use only
Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor 

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

  • limit time in the sun, especially from 10a.m.-2p.m.
  • wear long sleeved shirts, pants hats, and sunglasses.
Other Information

Protect this product from excessive heat and direct sun.

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients:

Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
Package Labeling:39892 0940 1 (Package Labeling:39892-0940-1)

Package Labeling:39892 0940 2 (Package Labeling:39892-0940-2)

Package Labeling:39892 0940 3 (Package Labeling:39892-0940-3)

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.


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