Otc - Active Ingredient
Zinc Oxide 17.68%
Biossance Squalane And Zinc Sheer Mineral Sunscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 84448-344
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thg Beauty Usa Llc for the product Biossance Squalane And Zinc Sheer Mineral Sunscreen Broad Spectrum Spf 30 (NDC 84448-344). 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
Sunscreen
Indications & Usage
Helps prevent sunburn.
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 eyes. 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 swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Shake well. Apply generously to face and neck 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. For adult use only.
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 value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.-2p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses.
Other Safety Information
Protect this product from excessive heat and direct sun.
Inactive Ingredient
WATER, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, POLYGLYCERYL-3 POLYRICINOLEATE, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, COCO-CAPRYLATE, SQUALANE, GLYCERIN, ECTOIN, BISABOLOL, CETYL ALCOHOL, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, HECTORITE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, SORBITAN ISOSTEARATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, HEDYCHIUM CORONARIUM ROOT EXTRACT, TOCOPHEROL, GLUCOSE.
Otc - Questions
1 833 794 1705
Package Label.Principal Display Panel
20ml (15398598 B1100046 344 P22096 01 Zincspf30 Usa 20ml Secondary Compressed Page 0001)
50ml (15243371 B1100312 344 P22096 01 Zincspf30 Usa 50ml Secondary Compressed Page 0001)
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