Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 1

Drug Labeling and Warnings

Drug Details [pdf]

GIVENCHY FLUID FOUNDATION AIRY-LIGHT MAT RADIANCE SPF 20 TINT 1- titanium dioxide cream 
LVMH Fragrance Brands

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.

----------

Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 1

Drug Facts

Active ingredient

Titanium Dioxide 3.16%

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

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 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 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

Other information

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

Inactive ingredients

Water, Methyl Trimethicone, Dimethicone, Alcohol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Silica, Isododecane, Acrylates / Dimethicone Copolymer, Phenyl Trimethicone, Phenoxyethanol, Stearic Acid, Alumina, Sodium Myristoyl Glutamate, Disteardimonium Hectorite, Fragrance, Tetrasodium EDTA, Propylene Carbonate, Aluminum Hydroxide, Sanguisorba Officinalis Root Extract, Carbomer, Butylphenyl Methylpropional, Cinnamomum Cassia Bark Extract, Sodium Stearate, Atelocollagen, Zinc Gluconate, Geraniol, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Extract, Sodium Chloride, BHT.

May Contain: Titanium Dioxide, Iron Oxides.

Product Label

GIVENCHY FLUID FOUNDATION AIRY-LIGHT MAT RADIANCE SPF 20 TINT 1 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60905-0401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CHINESE CINNAMON (UNII: WS4CQ062KM)
SODIUM STEARATE (UNII: QU7E2XA9TG)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
GERANIOL (UNII: L837108USY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GINGER (UNII: C5529G5JPQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60905-0401-1	1 in 1 PACKAGE	06/23/2011	05/01/2018
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/23/2011	05/01/2018

Labeler - LVMH Fragrance Brands (275474252)

Establishment
Name	Address	ID/FEI	Business Operations
LVMH Fragrance Brands		394954143	manufacture(60905-0401)

Revised: 10/2019

Document Id: 947b8599-324f-3676-e053-2995a90a7182

34390-5

Set id: a063e57f-564f-41d6-968a-ccbcaee2c6d7

Version: 5

Effective Time: 20191009