Otc - Active Ingredient
Avobenzone - 3%
Octisalate - 5%
Octocrylene - 10%
Hand Sunscreen Cream
FDA Label NDC 85448-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Senwo Medical Technology Co., Ltd. for the product Hand Sunscreen Cream (NDC 85448-002). 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 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
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
Apply generously and evenly 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin agingTo 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. Children under 6 months: Ask a doctor.
Inactive Ingredient
Inactive Ingredients
Water, Glycerin, Butylocty, Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanedtiol, Glyceryl StearateCitrate, Cocoglycerides, Isododecane, Cetyl Esters, CetylPhosphate, Diisopropyl Sebacate, IsodecylNeopentanoate, Lauryl, Lactate, Arginine, 1, 2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone,Polymethylsilsesquioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl Syingylidenemalonate, HelianthusAnnuus (Sunflower) Seed Wax, Limnanthes Alba(Meadowfoam) Seed Oil, Acrylates/C10-30 AlkylAcrylateCrosspolymer, Chlorphenesin, Xanthan Gum, Trisodium EthylenediamineDisuccinate, Argania Spinosa KernelOil, Caprylic/Capric Triglyceride, Citrus Nobilis (Mandarin Orange) Peel Oi, Plantago Lanceolata Leaf Extract,Glycine Soja(Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippopophae Rhamnoides Fruit Oil,ElettariaCardemomum Seed Oi, Eugenia Caryophyllus(Clove)Leaf Oil, Cinnamomum CassiaLeaf Oil, Vanillin,Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil
Other minor components
Butylene Glycol, Cetyl Alcohol Polyether-20, Stearoglycerin, EDTA Disodium, Ethylhexyl Stearate, Cactus Extract,Propylene Glycol, Xanthan Gum, Glycyrhza Root Extract, Oat Bran Extract, Hydroxy Kudzu Root Glycoside, PeonyRoot Extract, Kudzu Extract, Scutellaria Root Extract, Kudzu Glycoside
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
