28551f19-03a4-4f52-ad79-ab638a47ca55

SPL v3
SPL
SPL Set ID 28551f19-03a4-4f52-ad79-ab638a47ca55
Route
topical
Published
Effective Date 2015-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (19.6 mg) octisalate (49 mg) octocrylene (18.13 1) oxybenzone (4.9 mg)
Inactive Ingredients
carbomer copolymer type a allantoin aloe vera leaf n-butylphthalimide isopropylphthalimide alkyl (c12-15) benzoate caramel carbomer homopolymer type c (allyl pentaerythritol crosslinked) edetate disodium sunflower oil hypromelloses tea tree oil high density polyethylene polysorbate 20 cocoa butter olive oil oleth-10 phenoxyethanol propylene glycol sorbitan monooleate .alpha.-tocopherol acetate trolamine methylisothiazolinone polysilicone-15 water glycerin arabica coffee bean green tea leaf kakadu plum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
otc monograph final active Since 2013-10-22

Purpose

Sunscreen

Description

Avobenzone 2 %, Octisalate 5 %, Octocrylene 1.85 %, and Oxybenzone 0.5 %


Medication Information

Warnings

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
Purpose

Sunscreen

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 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
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Carbomer, Coffea Arabica (Kona Coffee) Seed Extract, 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, Phenoxyethanol, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Description

Avobenzone 2 %, Octisalate 5 %, Octocrylene 1.85 %, and Oxybenzone 0.5 %

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 60561-8

For external use only

Active Ingredients

Avobenzone 2 %, Octisalate 5 %, Octocrylene 1.85 %, and Oxybenzone 0.5 %

Questions Or Comments?

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

Principal Display Panel  237 ml  bottle Label

WITH KONA COFFEE

INFUSED BRONZERS

EXOTIC BLEND

#1 Fragrance

15

Lotion

Sunscreen

with instant

BRONZER

BROAD SPECTRUM SPF 15

WATER RESISTANT (80 MINUTES)

Australian

G old®

237 mL / 8 FL. Oz


Structured Label Content

Warnings

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
Purpose

Sunscreen

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 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
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Carbomer, Coffea Arabica (Kona Coffee) Seed Extract, 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, Phenoxyethanol, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

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 60561-8 (60561-8)

For external use only

Active Ingredients (Active ingredients)

Avobenzone 2 %, Octisalate 5 %, Octocrylene 1.85 %, and Oxybenzone 0.5 %

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)

WITH KONA COFFEE

INFUSED BRONZERS

EXOTIC BLEND

#1 Fragrance

15

Lotion

Sunscreen

with instant

BRONZER

BROAD SPECTRUM SPF 15

WATER RESISTANT (80 MINUTES)

Australian

G old®

237 mL / 8 FL. Oz


Advanced Ingredient Data


Raw Label Data

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