SPL v3
SPL
SPL Set ID c5ad40de-49ad-4e59-b601-fccffd2fc298
Route
TOPICAL
Published
Effective Date 2014-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (9.8 mg) Octocrylene (8.3 mg) Oxybenzone (4.9 mg)
Inactive Ingredients
Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Aloe Vera Leaf 3-butylphthalide Isopropylphthalimide Alkyl (c12-15) Benzoate Dimethicone Trimethylsiloxysilicate (m/q 0.6-0.8) Edetate Disodium Sunflower Oil Hypromelloses Tea Tree Oil Methylisothiazolinone Olive Oil Oleth-10 Phenoxyethanol Polysilicone-15 Propylene Glycol Sorbitan Monooleate .alpha.-tocopherol Acetate Trolamine Kakadu Plum Water Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-21

Description

Avobenzone 1 %, Octocrylene 0.85 %, and Oxybenzone 0.5 %


Medication Information

Description

Avobenzone 1 %, Octocrylene 0.85 %, and Oxybenzone 0.5 %

Uses
  • helps prevent sunburn
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.

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

Skin Cancer/Skin Aing Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 and apply to face. Use in a well-ventilated area
  • reapply
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabics - could cause discoloration
Active Ingredients

Avobenzone 1 %, Octocrylene 0.85 %, and Oxybenzone 0.5 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Oleth 10, Phenoxyethanol, Polysilicone-15, Propylene Glycol, Sorbitan Oleate,Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

Principal Display Panel  237 ml  bottle Label



EXOTIC BLEND

#1 Fragrance

4

Spray Gel Sunscreen

CLEAR

BROAD SPECTRUM SPF 4

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz


Structured Label Content

Uses
  • helps prevent sunburn
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.

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

Skin Cancer/Skin Aing Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 and apply to face. Use in a well-ventilated area
  • reapply
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor
Other Information (Other information)
  • protect this product from excesive heat and direct sun
  • avoid spraying on fabics - could cause discoloration
Active Ingredients (Active ingredients)

Avobenzone 1 %, Octocrylene 0.85 %, and Oxybenzone 0.5 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Oleth 10, Phenoxyethanol, Polysilicone-15, Propylene Glycol, Sorbitan Oleate,Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

Principal Display Panel  237 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label)



EXOTIC BLEND

#1 Fragrance

4

Spray Gel Sunscreen

CLEAR

BROAD SPECTRUM SPF 4

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz


Advanced Ingredient Data


Raw Label Data

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