Indications & Usage
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.
Aussie Betta Tallow Sunscreen Spf30 Cream
FDA Label NDC 87838-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aussie Betta Healthy Care Pty Ltd for the product Aussie Betta Tallow Sunscreen Spf30 (NDC 87838-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, dosage & administration, warnings, otc - keep out of reach of children, aussie betta tallow sunscreen spf30, otc - purpose, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure.
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours
Children under 6 months of age: Ask a doctor.
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product 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 swallowed, get medical help or contact a Poison Control Center right away
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Aussie Betta Tallow Sunscreen Spf30
Zinc Oxide 13%
Titanium Dioxide 6.4%
Aussie (Aussie)
Otc - Purpose
Sunscreen
Other Safety Information
Protect this product from excessive heat and direct sunlight.
Store at room temperature.
Inactive Ingredient
Aqua, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cetyl Ethylhexanoate, Methylpropandiol, Isododecane, Butylene Glycol, Dicaprylyl Carbonate, Octyldodecanol, Caprylyl Methicone, Octyldodecyl Stearoyl Stearate, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Polyhydroxystearic Acid, Triacontanyl PVP, Cetyl PEG/PPG-10/1 Dimethicone, Bis-Diglyceryl Polyacylcadipate-2, PEG-10 Dimethicone, Styrene/Stearyl Methacrylate Crosspolymer, Aluminum Starch Octenylsuccinate, Boron Nitride, Cetyl Dimethicone, Neopentyl Glycol Dicaprate, Ricinus Communis (Castor) Seed Oil, Styrene/Isoprene Copolymer, Glycerin, Triethoxysilyl Ethylsilane, Silica Dimethyl Silylate, Magnesium Sulfate, Behenyl Alcohol, Trihydroxystearin, Disteardimonium Hectorite, Alumina, Dimethicone, 3-O-Ethyl Ascorbic Acid, Ferulic Acid, Phenoxyethanol, Magnesium Aluminum Metasilicate, 1,2-Hexanediol, Hydroxyacetophenone, Tocopheryl Acetate, Adeps Bovis, Bisabolol, Ergothioneine, Fragrance, Ethylhexylglycerin, Disodium EDTA, Sodium Hyaluronate Crosspolymer, Sodium Acetylated Hyaluronate, Sodium Hyaluronate, Hydrolyzed Sodium Hyaluronate, Pentylene Glycol, BHT, BHA
Other
Distributor: Aussie Betta Healthy Care PTY LTD
Address: 1004/8 Central Park Ave Chippendale, NSW2008, Australia
Aussie Betta Tallow Sunscreen Spf50
Zinc Oxide 13%
Titanium Dioxide 6.4%
Octocrylene 6%
Ethylhexyl Salicylate 4%
Package Label.Principal Display Panel
Spf50 (Spf50)
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