PRISME PRIMER COLOR CORRECTING PRIMER SPF 20 PA SHADE 03 JAUNE- octinoxate, titanium dioxide cream

PRISME PRIMER Color Correcting Primer SPF 20 PA by

Drug Labeling and Warnings

PRISME PRIMER Color Correcting Primer SPF 20 PA by is a Otc medication manufactured, distributed, or labeled by LVMH Fragrance Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 4.00 %

Titanium Dioxide 2.37 %

Purpose

Sunscreen

Use

• 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

For external use only

Do not use

• on damaged or broken skin

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

Directions

• 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 decreases 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

Other information

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

Inactive ingredients

aqua (water), cyclopentasiloxane, butylene glycol, alcohol, cetyl peg/ppg-10/1 dimethicone, phenyl trimethicone, phenoxyethanol, sorbitan sesquioleate, aluminum hydroxide, dimethicone, stearic acid, disteardimonium hectorite, sodium myristoyl glutamate, calcium gluconate, tetrasodium EDTA, parfum (fragrance), propylene carbonate, viola tricolor extract, pentylene glycol, hydrolyzed rice protein, magnesium aspartate, zinc gluconate, BHT, ethylhexylglycerin, geraniol, rosa multiflora fruit extract, magnolia obovata bark extract, copper gluconate, pentaerythrityltetra-di-t-butyl hydroxyhydrocinnamate, tocopherol. [May contain: mica, CI 77891 (titanium dioxide), CI 77492 - CI 77491 (iron oxides)].

Questions or comments?

Call 1-855-424-8563

Monday-Friday 9am to 5pm EST

us.customerservice@lvmhfragrancebrands.com

Package Labeling

INGREDIENTS AND APPEARANCE

PRISME PRIMER COLOR CORRECTING PRIMER SPF 20 PA   SHADE 03 JAUNE
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60905-0063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GERANIOL (UNII: L837108USY)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
MAGNOLIA OBOVATA BARK (UNII: SM9Z2LD5TK)
COPPER GLUCONATE (UNII: RV823G6G67)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60905-0063-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2018

Labeler - LVMH Fragrance Brands (275474252)

Establishment
Name	Address	ID/FEI	Business Operations
LVMH Fragrance Brands		394954143	manufacture(60905-0063)