ULTA BEAUTY TINTED MOISTURIZER CREAM SPF 24 DEEP- avobenzone, homosalate, octisalate, octocrylene cream

Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep by

Drug Labeling and Warnings

Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep by is a Otc medication manufactured, distributed, or labeled by Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 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 ues 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 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: Ask a doctor

Inactive ingredients

water, glycerin, butylene glycol, triisostearyl citrate, titanium dioxide, pentylene glycol, polyglycerin-4, cetearyl olivate, candelilla/jojoba/rice bran polyglyceryl-3 esters, glyceryl stearate, phenoxyethanol, sorbitan olivate, potassium cetyl phosphate, cetearyl alcohol, sodium stearoyl latylate, oleyl alcohol, carbomer, olea europaea (olive) fruit oil, tromethamine, iron oxides, acacia senegal gum, ethylhexylglycerin, galactoarabinan, xanthan gum, betaine, citric acid, disodium edta, potassium sorbate, tremella fuciformis sporocarp extract

Other information

• protect this product from excessive heat and direct sun

Questions?

1-866-983-8582

Package Labeling:

INGREDIENTS AND APPEARANCE

ULTA BEAUTY TINTED MOISTURIZER CREAM SPF 24 DEEP 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERIN-4 (UNII: YX76MGM96B)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
OLIVE OIL (UNII: 6UYK2W1W1E)
TROMETHAMINE (UNII: 023C2WHX2V)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ACACIA (UNII: 5C5403N26O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
XANTHAN GUM (UNII: TTV12P4NEE)
BETAINE (UNII: 3SCV180C9W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-038-01	35 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2021

Labeler - Cosmax Usa, Corporation (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(68577-038)