ULTA SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

ULTA SUNSCREEN SPF 50 by

Drug Labeling and Warnings

ULTA SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by Ulta. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 1.5%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 1.2%, Oxybenzone 6.0%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

• May stain some fabrics

DOSAGE & ADMINISTRATION

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 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 of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients Water, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Cetyl Alcohol, Triethanolamine, Carbomer, Glyceryl Stearate, Behenyl Alcohol, Xanthan Gum, Sodium Lauroyl Sarcosinate, Disodium EDTA, Dipropylene Glycol, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Retinyl Palmitate, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methyldibromo Glutaronitrile, Methylchloroisothiazolinone, Methylisothiazolinone.

STORAGE AND HANDLING

Other information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

SUNCARE

BROAD SPECTRUM
SPF 50

WATER RESISTANT (80 MINUTES)

OIL-FREE

SUNSCREEN LOTION

ULTA

6 fl oz/ 176 ml

INGREDIENTS AND APPEARANCE

ULTA SUNSCREEN SPF 50  
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62296-3320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62296-3320-4	176 g in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/18/2015

Labeler - Ulta (608168597)