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

Ultra Violette Vibrant Screen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Ultra Violette Vibrant 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 10%
OCTISALATE 5.0%
OCTOCRYLENE 8.0%

SUNSCREEN

USE

HELPS PREVENT SUNBURN

if used as directed with other sun protections 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 contac a Poison Control Center right away

Directions

Directions for Sunscreen Use

apply liberally and evenly 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, Cera Alba, Cyclopentasiloxane, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Cyclohexasiloxane, Benzyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Hydroxyacetophenone, Saccharide Isomerate, Mica, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Carbomer, Fragrance, Citric Acid, Sodium Citrate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Other information

Other information protect the product in this container from excessive heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CETEARETH-20 (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
MICA (UNII: V8A1AW0880)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CARBOMER (UNII: 0A5MM307FC)
CI 77891 (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CI 77491 (UNII: 1K09F3G675)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-102-00	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2024

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)