SPL v3
SPL
SPL Set ID abcf9d29-c3eb-4326-b140-bcebbbad324e
Route
TOPICAL
Published
Effective Date 2013-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (75.1 mg) Octisalate (50.1 mg) Octocrylene (27.5 mg) Oxybenzone
Inactive Ingredients
Carbomer Copolymer Type A Allantoin Aloe Vera Leaf 3-butylphthalide Isopropylphthalimide Alkyl (c12-15) Benzoate Carbomer Homopolymer Type C Edetate Disodium Sunflower Oil Hypromelloses Melaleuca Alternifolia Leaf Methylisothiazolinone Methylparaben Black Olive High Density Polyethylene Polysilicone-15 Polysorbate 20 Propylene Glycol Green Tea Leaf Propylparaben Sorbitan Monooleate Sorbitol Cocoa Butter .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-19

Description

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


Medication Information

Description

Avobenzone 2 %, 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.

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

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
  • 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in 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
Active Ingredients

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance(Parfum), Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) leaf Oil, Methylisothiazolinone, Methylparaben, Olea Europaea (Olive ) Fruit Oil, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Camellia Sinensis ( Green Tea) Leaf Extract, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Principal Display Panel  237 Ml  bottle Label



EXOTIC BLEND

#1 Fragrance

KIDS

30

Lotion

Sunscreen

Moisture Max

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz


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.

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

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
  • 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in 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
Active Ingredients (Active ingredients)

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance(Parfum), Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) leaf Oil, Methylisothiazolinone, Methylparaben, Olea Europaea (Olive ) Fruit Oil, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Camellia Sinensis ( Green Tea) Leaf Extract, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

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



EXOTIC BLEND

#1 Fragrance

KIDS

30

Lotion

Sunscreen

Moisture Max

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz


Advanced Ingredient Data


Raw Label Data

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