SPL v3
SPL
SPL Set ID ed91c895-613f-4efc-80e2-a831d2934a54
Route
TOPICAL
Published
Effective Date 2013-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.8 mg) Homosalate (86 mg) Octisalate (43 mg) Octocrylene (23.7 mg) Oxybenzone (34.4 mg)
Inactive Ingredients
Alcohol Fd&c Blue No. 1 Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Fd&c Red No. 40 .alpha.-tocopherol Acetate Water Glycerin Acacia Senegal Flower Propylene Glycol Green Tea Leaf Arabica Coffee Bean Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-14

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, Oxybenzone 4 %


Medication Information

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, Oxybenzone 4 %

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. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in 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 10 %, Octisalate 5 %, Octocrylene 2.75 %, Oxybenzone 4 %

Inactive Ingredients

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

Principal Display Panel 177 Ml Can Label

EXOTIC BLEND

#1 Fragrance

Sheer Coverage

50

Continuous Spray

Sunscreen

Invisidry Technology

Kona Coffee

Infused Bronzers

BROAD SPECTRUM SPF 50

WATER RESISANT

(80 MINUTES)

Australian Gold

177 mL / 6 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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in 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 10 %, Octisalate 5 %, Octocrylene 2.75 %, Oxybenzone 4 %

Inactive Ingredients

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

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

EXOTIC BLEND

#1 Fragrance

Sheer Coverage

50

Continuous Spray

Sunscreen

Invisidry Technology

Kona Coffee

Infused Bronzers

BROAD SPECTRUM SPF 50

WATER RESISANT

(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz


Advanced Ingredient Data


Raw Label Data

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