GIVENCHY BLURRING FOUNDATION BALM BARE SKIN PERFECTOR - BROAD SPECTRUM SPF 15 NUDE SHELL- octinoxate, titanium dioxide emulsion

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Shell by

Drug Labeling and Warnings

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Shell 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 3.996%

Titanium Dioxide 2.19%

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, Cyclopentasiloxane, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenyl Trimethicone, Alcohol, Saccharide Isomerate, Polymethylsilsesquioxane, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Sorbitan Sesquioleate, Aluminum Hydroxide, Dimethicone, Sodium Myristoyl Glutamate, Stearic Acid, Disteardimonium Hectorite, Tocopheryl Acetate, Pentylene Glycol, Jasminum Officinale (Jasmine) Flower Extract, Fragrance, Propylene Carbonate, Tromethamine, Citric Acid, Sodium Citrate, Butylphenyl Methylpropional, Diamond Powder,
BHT, Geraniol, Tocopherol, Titanium Dioxide, Iron Oxides.

Product Labels

Sample Package Labeling:

INGREDIENTS AND APPEARANCE

GIVENCHY BLURRING FOUNDATION BALM BARE SKIN PERFECTOR - BROAD SPECTRUM SPF 15 NUDE SHELL 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60905-0041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	39.96 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	21.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALCOHOL (UNII: 3K9958V90M)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TROMETHAMINE (UNII: 023C2WHX2V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
DIAMOND (UNII: 6GRV67N0U2)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GERANIOL (UNII: L837108USY)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60905-0041-1	1 in 1 BOX	03/25/2015
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 60905-0041-2	10 mL in 1 TUBE; Type 0: Not a Combination Product	05/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/25/2015

Labeler - LVMH Fragrance Brands (275474252)

Establishment
Name	Address	ID/FEI	Business Operations
LVMH Fragrance Brands		394954143	manufacture(60905-0041)