ULTA Makeup Setting Spray SPF 50

ULTA by

Drug Labeling and Warnings

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

Drug Details [pdf]

ULTA SPF 50- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Packaging, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ULTA Makeup Setting Spray SPF 50

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. Do not inhale.

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
• 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 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

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 spraying on fabrics - could cause discoloration

Questions or comments?

Call 1-866-983-8582

Ulta Makeup Setting Broad Spectrum SPF 50

ULTA  SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0171
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
VINYL ACETATE (UNII: L9MK238N77)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
TEA TREE OIL (UNII: VIF565UC2G)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

Product Characteristics
Color	yellow (Light yellow to yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0171-3	100 mL in 1 CAN; Type 0: Not a Combination Product	03/04/2020	09/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/04/2020	09/28/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0171) , analysis(13630-0171)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0171) , pack(13630-0171)

Revised: 9/2022

Document Id: e9ba1a80-3513-cf6f-e053-2995a90ac3f1

34390-5

Set id: b08beef1-81e3-9584-e053-2995a90ae904

Version: 2

Effective Time: 20220928