OTC Medication Information: Australian Gold Botanical Broad Spectrum SPF 70

AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70- homosalate, avobenzone, octisalate and octocrylene spray
Prime Packaging, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swalowed, get medical help or contact a Poison Control Center right away.

Flammable: Avoid fire, flame heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C).

Directions

  • shake well before use
  • apply liberally 15 minutes before sun exposure and rub into skin
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly onto face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a 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 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Inactive ingredients

Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water/Aqua/Eau

Other information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics or surfaces

Questions or comments?

Call toll free 1-885-LIV-GOLD (548-4653)

Botanical Sunscreen 70 Broad Spectrum SPF 70 Natural Spray

Principal Display Label
(click image for full-size original)

AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0140
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 86.1 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 25.83 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 43.05 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 43.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
EUCALYPTUS GLOBULUS LEAF
PORPHYRA UMBILICALIS
.ALPHA.-TOCOPHEROL ACETATE
TRIMETHOXYBENZYLIDENE PENTANEDIONE
ISOBORNYL ACRYLATE
GLYCERIN
ALCOHOL
KAKADU PLUM
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
VINYL ACETATE
DIBUTYL MALEATE
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13630-0140-4 177 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 10/02/2018 02/28/2025
Labeler — Prime Packaging, Inc. (805987059)
Registrant — Prime Packaging, Inc. (805987059)
Establishment
Name Address ID/FEI Operations
Prime Enterprises, Inc. 101946028 manufacture (13630-0140), analysis (13630-0140)
Establishment
Name Address ID/FEI Operations
Prime Packaging, Inc. 805987059 label (13630-0140), pack (13630-0140)

Revised: 06/2022 Prime Packaging, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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