Otc - Active Ingredient
Zinc Oxide 24%
Dallas James Skincare Co. Spf 50 Sunscreen Cream
FDA Label NDC 83447-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Fantesy Biotechnology Co.,ltd for the product Dallas James Skincare Co. Spf 50 Sunscreen (NDC 83447-010). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
sunscreen
Uses
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
① For external use only.
② When using this product keep out of eyes.
Otc - Do Not Use
Do not use on damaged or broken skin.
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.
Directions
apply liberally 15 minutes before sun exposure & reapply:
■after 40 minutes of swimming or sweating
■immediately after towel drying
■at least every 2 hours
Other Information
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-sleeve shirts, pants, hats, and sunglasses.
■children under 6 n mornths: ask a doctor.
Inactive Ingredients
aqua, aloe barbadensis leaf juice, caprylic/ capric triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, hexyl laurate, cetyl
dimethicone, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, citrullus lanatus
(watermelon) fruit extract, rubus chamaemorus (cloudberry) fruit extract, niacinamide, centella asiatica extract, ceramide NP,
tocopherol (vitamin e), citrus limon (lemon) fruit extract, sodium hyaluronate, watermelon essential oil, potassium sorbate.
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