f5b35b42-f262-4134-8025-fe3a27ee51b3

SPL v3
SPL
SPL Set ID f5b35b42-f262-4134-8025-fe3a27ee51b3
Route
topical
Published
Effective Date 2013-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (24.9 mg) homosalate (62.3 mg) octisalate (41.5 mg) octocrylene (27.5 mg) oxybenzone (16.6 mg)
Inactive Ingredients
alcohol diethylhexyl 2,6-naphthalate polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) propylene glycol water green tea leaf .alpha.-tocopherol acetate glycerin acacia senegal flower

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph final active Since 2011-12-30

Description

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


Medication Information

Warnings

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
Directions
  • spray 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 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
Inactive Ingredients

Acacia Seneal Flower/Stem Extract, Camellia Sinensis (Green Tea) Leaf Extact, Diethlhexyl 2,6-Naphhalate, Fragrance (Parfum), Glycerin, Polyester-8, SD Alcohol 40-B (Alcohol Denat.), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

Description

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

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. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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

Active Ingredients

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

Principal Display Panel 177 Ml Can Label



EXOTIC BLEND

#1 Fragrance

Sheer Coverage

30

Continuous Spray

Sunscreen

Invisidry Technology

Oil- Free Formula

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

6 FL OZ (177 mL)


Structured Label Content

Warnings

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
Directions
  • spray 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 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
Inactive Ingredients

Acacia Seneal Flower/Stem Extract, Camellia Sinensis (Green Tea) Leaf Extact, Diethlhexyl 2,6-Naphhalate, Fragrance (Parfum), Glycerin, Polyester-8, SD Alcohol 40-B (Alcohol Denat.), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

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. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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

Active Ingredients (Active ingredients)

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

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



EXOTIC BLEND

#1 Fragrance

Sheer Coverage

30

Continuous Spray

Sunscreen

Invisidry Technology

Oil- Free Formula

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)