ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50- avonbenzone,homosalate,octisalate,octocrylene spray

Ultra Violette Preen Screen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Ultra Violette Preen 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]

AVONBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 6%

SUNSCREEN

HELPS PREVENT SUNBURN If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

Do not use on damaged or broken skin

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

Hold container 4 to 6 inches from skin to apply. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area and avoid inhalation. Apply liberally 15 minuts 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 sungasses. Children under 6 months of age: Ask a doctor.

Alcohol, Diisopropyl Adipate, Isododecane, Acrylates/Octylacrylamide, Copyolymer, Bisabolol, Niacinamide, Tocopheryl Acetate, Ascorbyl Tetraisopalmitate, Camella Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Helianthus Anuus (Sunflower) Seed Oil, Sodium Hyaluronate, Tocopherol, Silica, Dimethyl Silylate, Butyl Glycol, Phenoxyethanol, Ethylhexyl Palmitate, Capryl/ Glycol, Hexylene Glycol, Fragrance, Benzyl Salicylate, Hexyl Cinnamal, Linalool

Other Information. Protect this product from excessive heat and direct sun

Principal Display Panel

Ultra Violette

Preen Screen Broad Spectrum SPF 50 Reapplication Mist Skinscreen

1.7 FL. OZ. (50 mL) 1 FL. OZ (30mL)

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 
avonbenzone,homosalate,octisalate,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (-)- (UNII: 3U21E3V8I2)
CAMELLIA SINENSIS LEAF OIL (UNII: VC855RRT77)
HELIANTHUS ANNUUS (SUNFLOWER) SEED (UNII: R9N3379M4Z)
BISABOLOL (UNII: 24WE03BX2T)
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLES (UNII: WZ7DY7GBV6)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
NIACINAMIDE (UNII: 25X51I8RD4)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-101-50	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84803-101-30	30 mL in 1 BOTTLE, SPRAY; 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)