SPL v3
SPL
SPL Set ID f5b95bbd-d7af-451d-8d81-4e3a9665ad3e
Route
TOPICAL
Published
Effective Date 2015-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (16.1 mg) Homosalate (80.3 mg) Octisalate (40.2 mg) Oxybenzone (24.1 mg)
Inactive Ingredients
Alcohol Butyl Maleurate Isobornyl Acrylate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-28

Description

Avobenzone 2%, Homosalate 10%, Octisalate 5 %, and Oxybenzone 3 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2%, Homosalate 10%, Octisalate 5 %, and Oxybenzone 3 %

Uses
  • helps prevent sunburn
  • If use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Section 50565-1

Keep out of reach of children. If product is swallowed, 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. Keep away from face to avoid breathing it. Content is under pressure -  do not pumcture or incinerate. Do not store at temperature above 120°F.

Section 50570-1

Do not use: on damaged or broken skin

Section 60561-8

For external use only

Warnings

Directions
  • Hold container 4-6 inches from the skin & spray to apply. Spread evenly by hand 15 minuted before sun exposure
  • DO NOT spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions.
  • Use in a 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 & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:

  • limit time in the sun, especially from 10am - 2 pm
  • wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months:  Ask a doctor

Other Information
  • Protect this product from exessive heat and direct sunlight
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5 %, and Oxybenzone 3 %

inactive Ingredients

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label

Fair

&

Square

Ultra Protection

Sunscreen

Continuous Spray

15

Broad Spectrum

SPF 15

UVA/UVB Protection

Water Resistant (80 Minutes)

Oil-Free, Non-Greasy Formula

Compare to Coppertone

6 FL OZ (177 mL)


Structured Label Content

Uses
  • helps prevent sunburn
  • If use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, 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. Keep away from face to avoid breathing it. Content is under pressure -  do not pumcture or incinerate. Do not store at temperature above 120°F.

Section 50570-1 (50570-1)

Do not use: on damaged or broken skin

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

Directions
  • Hold container 4-6 inches from the skin & spray to apply. Spread evenly by hand 15 minuted before sun exposure
  • DO NOT spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions.
  • Use in a 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 & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:

  • limit time in the sun, especially from 10am - 2 pm
  • wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months:  Ask a doctor

Other Information
  • Protect this product from exessive heat and direct sunlight
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients (Active ingredients)

Avobenzone 2%, Homosalate 10%, Octisalate 5 %, and Oxybenzone 3 %

inactive Ingredients (Inactive ingredients)

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label (PRINCIPAL DISPLAY PANEL - 177 mL Can Label)

Fair

&

Square

Ultra Protection

Sunscreen

Continuous Spray

15

Broad Spectrum

SPF 15

UVA/UVB Protection

Water Resistant (80 Minutes)

Oil-Free, Non-Greasy Formula

Compare to Coppertone

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)