ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN- spf50 cream

ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN by

Drug Labeling and Warnings

ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN by is a Otc medication manufactured, distributed, or labeled by Grace And Fire USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

ZINC OXIDE 22.75%

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

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 doctor if

- rash occur

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

if swallowed , call a poison control centre or get medical help right away

Directions

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 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 10a.m.–
2p.m.  Wear long-sleeved shirts,
pants, hats, and sunglasses
 Children under 6 months of age:
Ask a doctor

Inactive Ingredients

Inactive Ingredients
Water, Coco-Caprylate/Caprate,
Octyldodecanol, Caprylic/Capric
Triglyceride, PEG-30
Dipolyhydroxystearate, Glycerin,
Polyglyceryl-3 Polyricinoleate,
Cetearyl Glucoside, Cetearyl Alcohol,
Gluconolactone, Isostearic Acid,
Sodium Chloride, Saccharide
Isomerate, Sodium Benzoate,
Xanthan Gum, Disodium EDTA,
Terminalia Ferdinandiana (Kakadu
Plum) Fruit Extract, Calcium
Gluconate, Citric Acid, Ammonium
Acryloyldimethyltaurate/VP
Copolymer, Sodium Citrate, Iron
Oxides (CI77492), Iron Oxides
(CI77491), Iron Oxides (CI77499).

Other Information

Protect this product from excessive heat and direct sun

Broad Spectrum SPF 50
Sunscreen PA++++
15ml

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN 
spf50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CI 77499 (UNII: XM0M87F357)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CI 77492 (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
GLYCERIN (UNII: PDC6A3C0OX)
CI 77491 (UNII: 1K09F3G675)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
2-ACETAMIDO-2-DEOXY-D-GLUCONO-1,5-LACTONE (UNII: 09ICI1V6AX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-106-02	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84803-106-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2024

Labeler - Grace And Fire USA Inc. (119357605)

Registrant - Grace And Fire USA Inc. (119357605)