ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM- avobenzone, octisalate, and octocrylene lotion

Ulta by

Drug Labeling and Warnings

Ulta 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 2%, Octisalate 5%, and Octocrylene 2.5%

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 & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

• protect from excesive heat & direct sunlight

QUESTIONS

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

ULTA

TINTED

SELF-TANNING

SUNSCREEN LOTION

BROAD

SPECTRUM

SPF 15

LIGHT

MEDIUM

NON-GREASY FORMULA

INSTANT, HEALTHY GLOW

BRONZE

6 FL OZ (177mL)

INGREDIENTS AND APPEARANCE

ULTA  SPF 15 LIGHT MEDIUM BROAD SPECTRUM
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
2,6-DI-TERT-BUTYL-4-((METHYLTHIO)METHYL)PHENOL (UNII: 650986R470)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARAMEL (UNII: T9D99G2B1R)
CETEARETH-22 (UNII: 28VZG1E234)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
L-ERYTHRULOSE (UNII: WKK1W5B83O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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: 58443-0127-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2008

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0127) , pack(58443-0127) , manufacture(58443-0127) , analysis(58443-0127)