Otc - Active Ingredient
Active Ingredients
Zinc Oxide (non-nano) 21 %
Broad Spectrum Spf30 Mineral Sunscreen Cream
FDA Label NDC 62742-4209
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Broad Spectrum Spf30 Mineral Sunscreen (NDC 62742-4209). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eye Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children If swadlowed get medical help or contact a poison control center right away
Dosage & Administration
Directions
Shake well before use
Apply generously 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending lime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with abroad Spectrum SPF value of 15 or higher and other sun protet-Wn measures including
Limit time in the sun, especial& from 10 arn.-2 p.m
Wear long-sleeved shirts, pants, hats and sunglasses
Children under 6 months of age Ask a doctor.
Other Safety Information
Other information
'
Protect the product in this conitainer from excessive heat and direct sun
May stain some fabrics
Inactive Ingredient
Inactive Ingredients
Water (Aqua)
Caprylic/Capric Triglyceride
Coconut Alkanes
Cetearyl Alcohol
Glycerin
Coco-Glucoside
Squalane
Butyrospermum Parkii Nut Extract
Aloe Barbadensis Leaf Juice
Cetearyl Glucoside
Coco-Caprylate/Caprate
Caprylyl/Capryl Glucoside
Hydrolyzed Jojoba Esters
Cucumis Sativus (Cucumber) Fruit Extract
sr-Hydrozoan Polypeptide-1
Polyhydroxystearic Acid
Polyglyceryl-3 Polyricinoleate
Isostearic Acid
Lecithin
SodiuM Ascorbyl Phosphate
Sclerotium Gum
Xanthan Gum
Ethylhexylglycerin
Sodium Phytate
Tocopheryl Acetate
Phenoxyethanol
Sodium Benzoate
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