Drug labels

ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen

BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE · Grace and Fire USA Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
56ad0dce-410e-9d78-e063-6294a90a1c3e
ID
56ad0dce-410f-9d78-e063-6294a90a1c3e
Effective time
20260809
Version
1
SPL product data elements

ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen bemotrizinol, octocrylene, zinc oxide BIXA ORELLANA SEED BEMOTRIZINOL BEMOTRIZINOL BENZYL ALCOHOL ORYZA SATIVA (RICE) BRAN OCTOCRYLENE OCTOCRYLENE CELLULOSE GUM SILICA DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES CITRIC ACID COPERNICIA CERIFERA (CARNAUBA) WAX CI 77499 PHENOXYETHANOL 3-CHLORO-6-HYDROXYACETOPHENONE MALTODEXTRIN XANTHAN GUM SODIUM HYDROXIDE PENTYLENE GLYCOL SODIUM STEAROYL GLUTAMATE ETHYL LINOLEATE EDETATE DISODIUM BUTYLOCTYL SALICYLATE HEPTYL UNDECYLENATE CETEARYL ALCOHOL ETHYLHEXYL METHOXYCRYLENE MICROCRYSTALLINE CELLULOSE TRIETHOXYCAPRYLYLSILANE POLYHYDROXYSTEARIC ACID (2300 MW) CI 77492 CI 77491 SODIUM CITRATE EPILOBIUM ANGUSTIFOLIUM LEAF SACCHARIDE ISOMERATE CETYL ALCOHOL LACTIC ACID SODIUM METABISULFITE ZINC OXIDE ZINC OXIDE

SPL unclassified section
Drug Facts
Active ingredient
Active ingredients Bemotrizinol 3% Octocrylene 6% Zinc Oxide 10%
Purpose
Purpose Sunscreen
Indications and usage
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

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.

Do not use
Do not use on damaged or broken skin
When using
When using this product keep out of eyes. Rinse with water to remove.
Stop use
Stop use and ask a doctor if rash occurs
Keep out of reach of children
Keep out of reach of children. if swallowed, call a poison control center or get medical help right away.
Dosage and administration

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 ingredient

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 safety information
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 PDP

Harmonized identifiers (openFDA)
Application number
M020
Brand name
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen
Generic name
BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE
Manufacturer name
Grace and Fire USA Inc.
Product NDC
84803-116
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE
SPL ID
56ad0dce-410f-9d78-e063-6294a90a1c3e
SPL set ID
56ad0dce-410e-9d78-e063-6294a90a1c3e
Package NDC
84803-116-50, 84803-116-05
Is original packager
true
Upc
9355909008864
UNII
PWZ1720CBH, 5A68WGF6WM, SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.