ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50- avobenzone,homosalate,octisalate,octocrylene cream

Ultra Violette Supreme Screen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Ultra Violette Supreme Screen Broad Spectrum SPF 50 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

AVOBENZONE 3.0%
HOMOSALATE 7.0%
OCTISALATE 5.0%
OCTOCRYLENE 8.0%

PURPOSE

SUNSCREEN

USE

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 a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center 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 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA,
Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).

Other Information

protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Ultra Violette

Supreme Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID (UNII: 33X04XA5AT)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
RICE BRAN (UNII: R60QEP13IC)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
NYLON-12 (UNII: 446U8J075B)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARNOSINE (UNII: 8HO6PVN24W)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TROLAMINE (UNII: 9O3K93S3TK)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-100-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84803-100-15	15 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2024
3	NDC: 84803-100-05	5 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)