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Drug Facts
Ultra Violette Unblock Screen Spf 50 Sunscreen Cream
FDA Label NDC 84803-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grace And Fire Usa Inc. for the product Ultra Violette Unblock Screen Spf 50 Sunscreen (NDC 84803-116). 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, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Bemotrizinol 3%
Octocrylene 6%
Zinc Oxide 10%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used with other sun protection measures (see Directions), decreases the risk of early skin aging caused by the sun
Warnings
For external use only.
Do Not Use
- on damaged or broken skin
When Using This Product
- keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
if rash occurs
Keep Out Of Reach Of Children.
if swallowed, call a poison control center or get medical help right away.
Directions
- apply liberally 15 minutes before sun exposure
- 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 decrase this risk, regularly use a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
Inactive Ingredients
water, butyloctyl salicylate, heptyl undecylenate, cetearyl alcohol, silica, ethylhexyl methoxycylene, copernicia cerifera (carnauba) wax, microcrystalline cellulose, saccharide isomerate, cetyl alcohol, phenoxyethanol, hydroxyacetophenone, disodium lauriminodipropionate tocopheryl phosphates, polyhydroxystearic acid, triethoxycaprylylsilane, cellulose gum, maltodextrin, benzyl alcohol, bixa orellana seed extract, epilobium angustifolium flower/leaf/stem extract, oryza sativa (rice) bran wax, sodium stearoyl glutamate, xanthan gum, disodium EDTA, ethyl linoleate, pentylene glycol, lactic acid, citric acid, sodium citrate, sodium metabisulfite, sodium hydroxide, iron oxides (CI 77492), iron oxides (CI77491), iron oxides (CI 77499)
Other Information
- Protect this product from heat and direct sun
Package Label.Principal Display Panel
Uses Next Gen UV Filter
ULTRA VIOLETTE
Unblock Screen
SPF 50
For Pores That Protest SPF
A SOFT-MATTE
AIRY CREAM FOR
BREAKOUT-PRONE SKIN
Broad Spectrum SPF 50
Sunscreen
5mL 0.16 fl oz
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