SPL v3
SPL
SPL Set ID 74a6dec2-c1bf-4396-988a-ef66604d83a3
Route
TOPICAL
Published
Effective Date 2015-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.4 mg) Homosalate (73.5 mg) Octisalate (49 mg) Octocrylene (26.95 mg) Oxybenzone (19.6 mg)
Inactive Ingredients
C10-30 Cholesterol/lanosterol Esters Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Aloe Vera Leaf N-butylphthalimide Isopropylphthalimide Dimethicone Trimethylsiloxysilicate (m/q 0.6-0.8) Edetate Disodium Sunflower Oil Hypromelloses Melaleuca Alternifolia Leaf Methylisothiazolinone Olive Oil Oleth-10 Phenoxyethanol Polysilicone-15 Propylene Glycol Sorbitan Monooleate .alpha.-tocopherol Acetate Trolamine Water Glycerin Kakadu Plum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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. Keep away from face to avoid breathing it.

Section 50570-1

Do not use on damaged or broken skin.

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread evenly 15 minutes before sun exposure
  • do not spray directly into face. 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 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 7.5 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, 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 Ferdinandiaria (Kakadum Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

Questions Or Comments?

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

Principal Display Panel  237 Ml  bottle Label



EXOTIC BLEND

#1 Fragrance

X-TREME

SPORT

30

Spray Gel

Sunscreen

Total Performance Formula

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

8 FL OZ (237 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. Keep away from face to avoid breathing it.

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
  • spray liberally and spread evenly 15 minutes before sun exposure
  • do not spray directly into face. 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 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 7.5 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, 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 Ferdinandiaria (Kakadum Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

Questions Or Comments? (Questions or Comments?)

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

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



EXOTIC BLEND

#1 Fragrance

X-TREME

SPORT

30

Spray Gel

Sunscreen

Total Performance Formula

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

8 FL OZ (237 mL) 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)