Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2db243d3-3b59-4be9-967c-0d4aea4d0066
Route
TOPICAL
Published
Effective Date 2013-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (5 g) Avobenzone (3 g) Octisalate
Inactive Ingredients
Alcohol Caprylyl Glycol Mineral Oil Peg-8 Dimethicone Aloe Vera Leaf Octyldodecanol Vitamin A Palmitate Silicon Dioxide .alpha.-tocopherol Acetate Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-09

Description

Avobenzone 3.0%, Octocrylene 10.0%, Oxybenzone 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Octocrylene 10.0%, Oxybenzone 5.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see directions), decrease the risk of skin cancer and early skin aging caused by the sun.



Warnings

For external use only

Flammable: Do not Puncture or incinerate, Contents under pressure.

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.



Directions:
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenlyb by hand 15 minutes before sun exposure
  • Do not spray directly on face.
  • Spray on hands then apply to face

  • do not apply in windy conditionss
  • use in well-ventiliated 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 increase 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 a.m.- 2 p.m
  • wear long -sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age:
  • Ask a doctor

Other Information

protect this product from excessive heat and direct sun



Active Ingredients

Avobenzone 3.0%, Octocrylene 10.0%, Oxybenzone 5.0%





Inactive Ingredients:

Alcohol decant, Acrylates/octylacrylamide Copolymer, Caprylyl Glycol, Mineral Oil, PEG_8 Dimethicone, Aloe Barbadensis Leaf Extract, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Leaf Extract, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance.



Principal Display Panel

PETER

ISLAND

Continous Spray Sunscreen

Kids 50

BROAD SPECTRUM

SPF 50

Won't Run Into Eyes

UVA/UVB Protection

Water Resistant(80 minutes)

6 FL.OZ. (177 mL)

When Using This Product
  • Keep away from face to avoid breaching 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.

  • May stain some fabrics.
  • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.




Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see directions), decrease the risk of skin cancer and early skin aging caused by the sun.



Purpose

Sunscreen

Warnings

For external use only

Flammable: Do not Puncture or incinerate, Contents under pressure.

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.



Directions: (DIRECTIONS:)
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenlyb by hand 15 minutes before sun exposure
  • Do not spray directly on face.
  • Spray on hands then apply to face

  • do not apply in windy conditionss
  • use in well-ventiliated 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 increase 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 a.m.- 2 p.m
  • wear long -sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age:
  • Ask a doctor

Other Information

protect this product from excessive heat and direct sun



Active Ingredients (Active ingredients)

Avobenzone 3.0%, Octocrylene 10.0%, Oxybenzone 5.0%





Inactive Ingredients:

Alcohol decant, Acrylates/octylacrylamide Copolymer, Caprylyl Glycol, Mineral Oil, PEG_8 Dimethicone, Aloe Barbadensis Leaf Extract, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Leaf Extract, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance.



Principal Display Panel

PETER

ISLAND

Continous Spray Sunscreen

Kids 50

BROAD SPECTRUM

SPF 50

Won't Run Into Eyes

UVA/UVB Protection

Water Resistant(80 minutes)

6 FL.OZ. (177 mL)

When Using This Product (When using this product)
  • Keep away from face to avoid breaching 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.

  • May stain some fabrics.
  • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.




Advanced Ingredient Data


Raw Label Data

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