ULTA BEAUTY BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Ulta Beauty by

Drug Labeling and Warnings

Ulta Beauty by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

Purpose

Sunscreen

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 a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Alcohol Denat, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Benzyl Alcohol, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cyclopentasiloxane, Dehydroacetic Acid, Fragrance, Glycerin, Polyester-8, Rosa Damascena Flower Water, Silica Silylate, Sodium Hyaluronate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other Information

• protect this product from excessive heat and direct sun
• avoid contact with fabrics - could cause discoloration

Question or comments?

Call 1-866-983-8582

Ulta Beauty SPF 50 Broad Spectrum Sunscreen

INGREDIENTS AND APPEARANCE

ULTA BEAUTY  BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0323
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	46.45 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	37.16 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25.55 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27.87 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	92.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIBUTYL MALEATE (UNII: 4X371TMK9K)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALCOHOL (UNII: 3K9958V90M)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MIDAMALINE HYDROCHLORIDE (UNII: 4CVP92LH8L)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
LEVOMENOL (UNII: 24WE03BX2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0323-3	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/04/2020

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0323) , manufacture(58443-0323) , label(58443-0323) , analysis(58443-0323)