SPL v3
SPL
SPL Set ID 9258acd6-a56d-4883-9f08-1213e181a80b
Route
TOPICAL
Published
Effective Date 2014-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.1 mg) Homosalate (62.7 mg) Octisalate (41.8 mg) Octocrylene (22.9 mg) Oxybenzone (16.7 mg)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Alcohol Fd&c Red No. 40 Dibutyl Maleate Water Glycerin Kakadu Plum Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-06

Description

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %


Medication Information

Description

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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
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.

Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Directions

  • apply liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • 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 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration.
Active Ingredients

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Blue 1 (CI 42090), Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Water (Aqua), Yellow 5 (CI 19140)

Principal Display Panel  177 ml  bottle Label

EXOTIC BLEND

#1 Fragrance

30

Continuous Spray Sunscreen

with instant

BRONZER

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Australian

Gold

6 FL OZ (177 mL)


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
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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Directions

  • apply liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • 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 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information (Other information)
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration.
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Blue 1 (CI 42090), Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Water (Aqua), Yellow 5 (CI 19140)

Principal Display Panel  177 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label)

EXOTIC BLEND

#1 Fragrance

30

Continuous Spray Sunscreen

with instant

BRONZER

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Australian

Gold

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

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