Otc - Active Ingredient
Active ingredient
Zinc Oxide 15.6%
Prevention Sun Serum Spf30 Cream
FDA Label NDC 62742-4225
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 Prevention Sun Serum Spf30 (NDC 62742-4225). 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 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 before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses
Other Safety Information
Other information • protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients:
ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, LECITHIN, TOCOPHERYL ACETATE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.
Package Label.Principal Display Panel
Prevention Sun Serum (Preventionsunserum)
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