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Drug Facts
Sun ,bug Handsfree Cream
FDA Label NDC 82953-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Sun , Bug Handsfree (NDC 82953-010). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%
Homosalate 10%
Octocrylene 10%
Octisalate 5%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then 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 prduct is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediate after towel drying
- at least every 2 hours
- Sun Protection Measures
- limit time in the sun, especially from 10a.m.- 2p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- children under 6 months:Ask a doctor
Spending time increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Inactive Ingredients
Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Citronella oil, Lemongrass oil, peppermint oil, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT
* Please review the disclaimer below.
