SPL v3
SPL
SPL Set ID 78316030-1177-4e41-a913-f5412ac2ee8f
Route
TOPICAL
Published
Effective Date 2013-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (4.03 mg) Octocrylene (8.06 mg) Oxybenzone
Inactive Ingredients
Alkyl (c12-15) Benzoate Fd&c Blue No. 1 Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Fd&c Red No. 40 Alcohol Fd&c Yellow No. 5 Water

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-21

Description

Avobenzone 0.5%, Octocrylene 1%, Oxybenzone 0.5%


Medication Information

Description

Avobenzone 0.5%, Octocrylene 1%, Oxybenzone 0.5%

Uses
  • helps prevent sunburn
Section 42229-5

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.

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

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 on face. Spray into hands and 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
  • 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 0.5%, Octocrylene 1%, Oxybenzone 0.5%

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Yellow 5 (CI 19140), Water (Aqua)

Principal Display Panel 177 Ml Can Label

Exotic Blend

#1 Fragrance

4

Continuous Spray Sunscreen

with instant BRONZER

BROAD SPECTRUM SPF 4

WATER RESISTANT(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz


Structured Label Content

Uses
  • helps prevent sunburn
Section 42229-5 (42229-5)

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.

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)

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 on face. Spray into hands and 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
  • 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 0.5%, Octocrylene 1%, Oxybenzone 0.5%

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Yellow 5 (CI 19140), Water (Aqua)

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

Exotic Blend

#1 Fragrance

4

Continuous Spray Sunscreen

with instant BRONZER

BROAD SPECTRUM SPF 4

WATER RESISTANT(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)