SPL v3
SPL
SPL Set ID 7de466cf-0718-410f-aab1-b7e539b34567
Route
TOPICAL
Published
Effective Date 2015-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.8 mg) Homosalate (64.5 mg) Octisalate (43 mg) Octocrylene (23.7 mg) Oxybenzone (17.2 mg)
Inactive Ingredients
Fd&c Blue No. 1 Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Fd&c Red No. 40 Dibutyl Maleate Isobornyl Acrylate Glycerin Propylene Glycol Acacia Senegal Flower Kakadu Plum Green Tea Leaf Coffea Arabica Seed, Roasted Fd&c Yellow No. 5 Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-10-22

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. Content under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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 by hand 15 minutes before sun exposure
  • Children under 6 months: Ask a doctor
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray hands then apply to face.
  • Do not apply in windy conditions. Use in well ventilated areas.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
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

Acacia Senegal Flower/Stem Extract, Blue 1 (Cl 42090), Camellia Sinensis (Green Tea) Leaf Extract, Coddea Arabica (Kona Coffee) Seed Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, Red-40 (Cl 16035), SD Alcohol 40-B (Alcohol Denat), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, TocopherylAcetate, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Water (Aqua), Yellow 5 (Cl 19140)

Questions Or Comments?

Call toll free 1-800-LIV-GOLD (548-4653)

Principal Display Panel 177 Ml Can Label

Exotic Blend

#1 Fragrance

Sheer Coverage

30

Continuous Spray

Sunscreen

Invisidry™ Technology

Kona Coffee

Infused Bronzers

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

Autralian

G old®

177 mL / 6Fl. 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. Keep away from face to avoid breathing it. Content under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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 by hand 15 minutes before sun exposure
  • Children under 6 months: Ask a doctor
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray hands then apply to face.
  • Do not apply in windy conditions. Use in well ventilated areas.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
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

Acacia Senegal Flower/Stem Extract, Blue 1 (Cl 42090), Camellia Sinensis (Green Tea) Leaf Extract, Coddea Arabica (Kona Coffee) Seed Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, Red-40 (Cl 16035), SD Alcohol 40-B (Alcohol Denat), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, TocopherylAcetate, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Water (Aqua), Yellow 5 (Cl 19140)

Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-LIV-GOLD (548-4653)

Principal Display Panel 177 Ml Can Label (PRINCIPAL DISPLAY PANEL - 177 mL Can Label)

Exotic Blend

#1 Fragrance

Sheer Coverage

30

Continuous Spray

Sunscreen

Invisidry™ Technology

Kona Coffee

Infused Bronzers

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

Autralian

G old®

177 mL / 6Fl. Oz


Advanced Ingredient Data


Raw Label Data

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