ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 07- octinoxate liquid 
Make Up For Ever S.A

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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ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 07

Drug Facts

Active Ingredients

Octinoxate 6.74%
Titanium Dioxide 2.28%

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 out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• 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.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

AQUA (WATER) • CYCLOPENTASILOXANE • GLYCERIN • ISODODECANE • PENTYLENE GLYCOL • ALCOHOL • DIMETHICONE • VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER • PEG-10 DIMETHICONE • XANTHAN GUM • SORBITAN SESQUIOLEATE • DISTEARDIMONIUM HECTORITE • PHENOXYETHANOL • ACRYLATES/ DIMETHICONE COPOLYMER • SILICA • ALUMINUM HYDROXIDE • ISOSTEARIC ACID • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • POLYHYDROXYSTEARIC ACID • SODIUM MYRISTOYL GLUTAMATE • SILICA SILYLATE • PROPYLENE CARBONATE • PARFUM (FRAGRANCE) • STEARIC ACID • BENZYL BENZOATE • SYNTHETIC FLUORPHLOGOPITE
• SODIUM METABISULFITE • BHT • TOCOPHEROL • [+/- : CI 77491, CI 77492, CI 77499 (IRON OXIDES) • CI 77891 (TITANIUM DIOXIDE) •].
12086/Z

Question or Comments ?

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Package Labeling:

Outer Package5Inner Package5

ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 07 
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71813-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67.4 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BENZYL BENZOATE (UNII: N863NB338G)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71813-007-001 in 1 TUBE10/24/201712/15/2020
130 mL in 1 BOX; Type 0: Not a Combination Product
2NDC:71813-007-011 in 1 TUBE10/24/201712/15/2020
215 mL in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/24/201712/15/2020
Labeler - Make Up For Ever S.A (267703718)

Revised: 11/2020
Document Id: b34b9bde-6fe0-4bdf-e053-2995a90a2762
Set id: 999e7077-933a-4200-8936-71649024b1de
Version: 5
Effective Time: 20201104
 
Make Up For Ever S.A