SPL v3
SPL
SPL Set ID 4f1e70f9-9185-466b-8e19-6f7d06192626
Route
TOPICAL
Published
Effective Date 2015-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (26.7 mg) Homosalate (89 mg) Octisalate (44.5 mg) Octocrylene (24.5 mg) Oxybenzone (35.6 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Diethylhexyl 2,6-naphthalate Diisopropyl Adipate Trioctyldodecyl Citrate Phenethyl Benzoate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Alcohol Water .alpha.-tocopherol Acetate Tridecyl Neopentanoate Dibutyl Maleate Propylene Glycol Artemisia Princeps Leaf Buddleja Davidii Leaf Isobornyl Acrylate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-25

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 4 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 4 %

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. 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 broken or damaged skin

Section 60561-8

For external use only

Warnings

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 areas
  • 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
Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 4 %

Inactive Ingredients

Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Adipate, Fragrance (Parfum), Octyldodecyl Citrate Crosspolymer, Phenethyl Benzoate, Polyester-8, Propylene Glycol, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Questions Or Comments?

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

Principal Display Panel 150 Ml Can Label

Australian G old®

HELLO

KITTY

Wet/Dry Skin Formula

Body Mist Sunscreen

Paradise Pineapple

50

BROAD SPECTRUM SPF 50

Water Resistant (80 minutes)

5 FL OZ (150mL)


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. 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 broken or damaged skin

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

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 areas
  • 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
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 4 %

Inactive Ingredients

Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Adipate, Fragrance (Parfum), Octyldodecyl Citrate Crosspolymer, Phenethyl Benzoate, Polyester-8, Propylene Glycol, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel 150 Ml Can Label (PRINCIPAL DISPLAY PANEL - 150 mL Can Label)

Australian G old®

HELLO

KITTY

Wet/Dry Skin Formula

Body Mist Sunscreen

Paradise Pineapple

50

BROAD SPECTRUM SPF 50

Water Resistant (80 minutes)

5 FL OZ (150mL)


Advanced Ingredient Data


Raw Label Data

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