Otc - Active Ingredient
Active ingredients
Homosalate 10.00%
Octinoxate 7.50%
Oxybenzone 6.00%
Octisalate 5.00%
Avobenzone 3.00%
Advanced Sun Resistance Spf 30 Cream
FDA Label NDC 65278-319
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Labs, Llc for the product Advanced Sun Resistance Spf 30 (NDC 65278-319). 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
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 product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses
■ Reapply at least every 2 hours
■ Use a water resistant sunscreen if swim ming or sweating
■ Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral
Other Safety Information
Other information
■ Protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments?
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