OTC Medication Information: Austalian Gold SPF 6 Sunscreen LOW PROTECTION

AUSTALIAN GOLD SPF 6 SUNSCREEN LOW PROTECTION- octocrylene, oxybenzone and avobenzone spray
Prime Enterprises 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 1%

Octocrylene 0.85%

Oxybenzone 0.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

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 help prevent sunburn, not skin cancer or early skin aging.

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 into face. Spray on hands then apply to face
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Acetylated Lanolin Alcohol, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidenemalonate, Fragrance, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other Information

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

Questions or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Australian Gold Spray Oil Sunscreen Hydrating formula SPF 6 LOW PROTECTION

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

AUSTALIAN GOLD SPF 6 SUNSCREEN LOW PROTECTION
n/a spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0318
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 7.65 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 4.5 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TEA TREE OIL
ACETYLATED LANOLIN ALCOHOLS
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
.ALPHA.-TOCOPHEROL ACETATE
BUTYLATED HYDROXYTOLUENE
LANOLIN ACID
SOYBEAN OIL
LIMONENE, (+)-
FRAGRANCE LAVENDER & CHIA F-153480
SUNFLOWER OIL
OLIVE OIL
KAKADU PLUM
ALOE VERA LEAF
CETYL ACETATE
CARROT SEED OIL
COCOA BUTTER
CITRAL
LINALOOL, (+/-)-
COUMARIN
DIETHYLHEXYL SYRINGYLIDENEMALONATE
MEDIUM-CHAIN TRIGLYCERIDES
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58443-0318-4 237 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/30/2017
Labeler — Prime Enterprises Inc. (101946028)
Registrant — Prime Enterprises Inc. (101946028)
Establishment
Name Address ID/FEI Operations
Prime Enterprises Inc. 101946028 pack (58443-0318), manufacture (58443-0318), label (58443-0318), analysis (58443-0318)

Revised: 09/2022 Prime Enterprises 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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