SPL v3
SPL
SPL Set ID 95a80ceb-8185-4c6a-a976-6853c2937a9e
Route
TOPICAL
Published
Effective Date 2013-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (8.4 mg) Octocrylene (7.1 mg) Oxybenzone (4.2 mg)
Inactive Ingredients
Alcohol Fd&c Blue No. 1 Alkyl (c12-15) Benzoate Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Fd&c Red No. 40 Water Glycerin Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-15

Description

Avobenzone 1 %, Octocrylene 0.85 %, Oxybenzone 0.5 %


Medication Information

Description

Avobenzone 1 %, Octocrylene 0.85 %, Oxybenzone 0.5 %

Uses
  • helps prevent sunburn
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

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.

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
  • 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 1 %, Octocrylene 0.85 %, Oxybenzone 0.5 %

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diehylhexyl 2,6-Napthalate, Fragrance (Parfum), Glycerin, Polyeser-8, Red 40 (CI 16035),  SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Water (Aqua), Yellow 5 (CI 19140)

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

6 Fl. Oz (177 mL)


Structured Label Content

Uses
  • helps prevent sunburn
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

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.

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
  • 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 1 %, Octocrylene 0.85 %, Oxybenzone 0.5 %

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diehylhexyl 2,6-Napthalate, Fragrance (Parfum), Glycerin, Polyeser-8, Red 40 (CI 16035),  SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Water (Aqua), Yellow 5 (CI 19140)

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

6 Fl. Oz (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)