ULTA BEAUTY SPF 50 WORKOUT SUNSCREEN FACE MIST WITH ROSEWATER- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Ulta Beauty by

Drug Labeling and Warnings

Ulta Beauty by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc., 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. Keep away from face to avoid breathing it.

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.

Flammable: Do not use near heat, flame or while smoking.

Directions:

• shake well
• close eyes completely. Mist over face evenly, holding bottle 10-12 inches away from face. Do not breathe mist in. Wait until dry.
• apply liberally and evenly 15 minutes before sun exposure.
• do not apply in windy conditions.
• use in a well ventilated area
• reapply:
• after 80 minutes of swimming or sweating
• inmediately 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 a 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 ingredients:

SD Alcohol 40-B, Cyclopentasiloxane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water, Silica Silylate, Rosa Damascena Flower Water, Mentha Viridis (Spearmint) Leaf Oil, Bisabolol, Polyester-8, Tocopheryl Acetate, Ascorbyl Palmitate, Glycerin, Camellia Oleifera (Green Tea) Leaf Extract, Benzyl Alcohol, Aloe Barbadensis Leaf Juice Powder, Dehydroacetic Acid, Sodium Hyaluronate.

Other Information:

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

Question or comments?

Call 1-866-983-8582

ULTA Beauty ACTIVE SPF 50 WORKOUT SUNSCREEN FACE MIST WITH ROSEWATER

INGREDIENTS AND APPEARANCE

ULTA BEAUTY  SPF 50 WORKOUT SUNSCREEN FACE MIST WITH ROSEWATER
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	24.75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SPEARMINT OIL (UNII: C3M81465G5)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WATER (UNII: 059QF0KO0R)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
LEVOMENOL (UNII: 24WE03BX2T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	yellow (Very light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0254-3	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2018

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(58443-0254) , analysis(58443-0254) , pack(58443-0254) , label(58443-0254)