Sun Bum Spf 30 Premium Moisturizing Sunscreen (spray)

Sun Bum Spf 30 Premium Moisturizing Sunscreen (spray)
SPL v4
SPL
SPL Set ID 8b68a40f-7856-47d4-a52f-db99cc0132b4
Route
TOPICAL
Published
Effective Date 2017-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (37.5 mg)
Inactive Ingredients
Alcohol Alkyl (c12-15) Benzoate Dicaprylyl Carbonate Ppg-5-ceteth-20 Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-26

Description

Avobenzone 3.00%, Homosalate 10.00%, Octisalate 5.00%, Octocrylene 3.75%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00%, Homosalate 10.00%, Octisalate 5.00%, Octocrylene 3.75%

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

Flammable: Contents under pressure. Do not puncture or inciinerate. Do not store at temperatures above 120°F. Do  not use in the presence of a flame or spark keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions
  • Hold container 4 to 6 inches from the skin to apply.
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • Do not spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions. Use in well-ventilated area.
  • 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 this 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 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
Do Not Use 

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%,

Octisalate 5.00%, Octocrylene 3.75%

Inactive Ingredients

Alcohol Denat.(67%), Acrylates/Octylacrylamide Copolymer, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, PPG-5-Ceteth-20, Fragrance, Tocopherol

Questions Or Comments?

Call +1 (877) 978-6286

When Using This Product:

Keep away from face to avoid breathing it. 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 product is swallowed, get medical help or contact a Poison Control Center right away.


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.
Purpose

Sunscreen

Warnings

Flammable: Contents under pressure. Do not puncture or inciinerate. Do not store at temperatures above 120°F. Do  not use in the presence of a flame or spark keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions
  • Hold container 4 to 6 inches from the skin to apply.
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • Do not spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions. Use in well-ventilated area.
  • 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 this 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 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
Do Not Use  (Do not use )

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%,

Octisalate 5.00%, Octocrylene 3.75%

Inactive Ingredients

Alcohol Denat.(67%), Acrylates/Octylacrylamide Copolymer, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, PPG-5-Ceteth-20, Fragrance, Tocopherol

Questions Or Comments? (Questions or Comments?)

Call +1 (877) 978-6286

When Using This Product: (When using this product:)

Keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children . (Keep out of reach of children .)

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


Advanced Ingredient Data


Raw Label Data

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