SPL v3
SPL
SPL Set ID acc957b7-e02c-4e22-80e0-ce6cb891f98e
Route
TOPICAL
Published
Effective Date 2013-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (4.9 mg) Octocrylene (19.4 mg) Oxybenzone (14.6 mg)
Inactive Ingredients
Carbomer Copolymer Type A Butylated Hydroxytoluene 3-butylphthalide Isopropylphthalimide Cetyl Alcohol Edetate Disodium Methylisothiazolinone Methylparaben Phenyl Trimethicone High Density Polyethylene Polysilicone-15 Potassium Cetyl Phosphate Potassium Hydroxide Propylene Glycol Water Glycyrrhiza Glabra Leaf Propylparaben Silicon Dioxide Stearyl Alcohol Styrene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-18

Description

Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %


Medication Information

Description

Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

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.

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 Aging 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
  • apply liberally 15 minutes before sun exposure
  • 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
Active Ingredients

Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT (Butylated Hydroxytoluene), Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Principal Display Panel 177 ml  tube Label



EXOTIC BLEND

#1 Fragrance

Sheer Coverage

8

Lotion Sunscreen

InvisiDry Technology

Clean and Hydrating

Broad Spectrum SPF 8

WATER RESISTANT

(80 MINUTES)

Australian

Gold

177 mL / 6 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.

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 Aging 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
  • apply liberally 15 minutes before sun exposure
  • 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
Active Ingredients (Active ingredients)

Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT (Butylated Hydroxytoluene), Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Principal Display Panel 177 ml  tube Label (PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label)



EXOTIC BLEND

#1 Fragrance

Sheer Coverage

8

Lotion Sunscreen

InvisiDry Technology

Clean and Hydrating

Broad Spectrum SPF 8

WATER RESISTANT

(80 MINUTES)

Australian

Gold

177 mL / 6 Fl. Oz


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)