FDA Label for Dry Touch Sunscreen Spf 50
View Indications, Usage & Precautions
Dry Touch Sunscreen Spf 50 Product Label
The following document was submitted to the FDA by the labeler of this product Media Networks Sydney Pty Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Dosage & Administration
Dosage Form Lotion Route of Administration Topical
The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept. The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request. Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor. The following two conditions apply where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the product with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products - Evaluation and classification (the Sunscreen Standard): a) The sponsor is required to hold adequate supplementary in-vitro testing data and/or relevant testing data from an independent testing laboratory on a comparable formulation, or other justification acceptable to the TGA, to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the product. b) The sponsor must provide the data, documentation or other justification to the TGA within 10 working days of a request by the TGA, or as deemed reasonable by the delegate upon request.
Warnings
May be irritant to the eyes (or words to that effect) Avoid contact with eyes (or words to that effect). Contains phenethyl alcohol (or words to that effect). Contains phenoxyethanol (or words to that effect). Avoid prolonged exposure in the sun.[or words to that effect] Wear protective clothing, hats and eyewear when exposed to the sun.[Or words to this effect]
Inactive Ingredient
Other Ingredients (Excipients) acrylates/dimethicone copolymer alkyl (C12-15) benzoate caprylyl glycol cetyl dimethicone copolyol cetyl dimeticone/bis-vinyldimeticone crosspolymer cetyl dimeticone chlorphenesin dimeticone 2 dimeticone 50 ethyl meticone glycerol glyceryl behenate octyldodecyl citrate crosspolymer PEG-8 laurate pentylene glycol phenethyl alcohol phenoxyethanol phenyl trimethicone polyhydroxystearic acid purified water silicon dioxide sodium chloride styrene/acrylates copolymer Tanacetum parthenium triethoxycaprylylsilane
Indications & Usage
Products 1 . Neutrogena SheerZinc Dry-Touch Sunscreen Lotion Product Type Single Medicine Product Effective Date 9/06/2021 Permitted Indications May assist in preventing some skin cancers (sunscreen) May reduce the risk of some skin cancers (sunscreen) SPF 50 Broad spectrum high protection sunscreen Can aid in the prevention of premature skin ageing (sunscreen) Can aid in the prevention of solar keratosis (sunscreen) Can aid in the prevention of sunspots (sunscreen) Indication Requirements Indication can only be used for sunscreen products with an SPF rating of 30 or higher. Indication for use in sunscreen products only.
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children Section
Otc - Purpose
ARTG entry for Medicine Listed Sponsor Johnson & Johnson Pacific Pty Ltd Postal Address Locked Bag 5, BROADWAY, NSW, 2007 Australia ARTG Start Date 17/08/2016 Product Category Medicine Status Active Approval Area Listed Medicines
Otc - Active Ingredient
Active Ingredients zinc oxide 216 mg/g
Package Label.Principal Display Panel
Summary for ARTG Entry: 279242 Neutrogena SheerZinc Dry-Touch Sunscreen Lotion ARTG entry for Medicine Listed Sponsor Johnson & Johnson Pacific Pty Ltd Postal Address Locked Bag 5, BROADWAY, NSW, 2007 Australia ARTG Start Date 17/08/2016 Product Category Medicine Status Active Approval Area Listed Medicines
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