GIORGIO ARMANI DESIGNER LIFT SMOOTHING FIRMING FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN- octinoxate and titanium dioxide lotion

Giorgio Armani Designer Lift Smoothing Firming Foundation Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Giorgio Armani Designer Lift Smoothing Firming Foundation Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Sicos et Cie. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Titanium dioxide 1.9%

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 use and ask a doctor if

rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use:

● shake well before 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 value 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-sleeved 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, phenyl trimethicone, cyclohexasiloxane, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, pentylene glycol, polyglyceryl-4 isostearate, fragrance, tocopherol, phenoxyethanol, adenosine, magnesium sulfate, PEG-10 dimethicone, PEG/PPG-18/18 dimethicone, ethylhexylglycerin, cellulose gum, silica, limonene, benzyl salicylate, benzyl alcohol, linalool, synthetic fluorphlogopite, sorbitol, acrylates copolymer, disodium stearoyl glutamate, methylsilanol/silicate crosspolymer, butylphenyl methylpropional, aluminum hydroxide, alumina, hexyl cinnamal; may contain: iron oxides, ferric ferrocyanide, bismuth oxychloride, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GIORGIO ARMANI DESIGNER LIFT SMOOTHING FIRMING FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ADENOSINE (UNII: K72T3FS567)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SORBITOL (UNII: 506T60A25R)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC FERROCYANIDE (UNII: TLE294X33A)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-182-01	1 in 1 CARTON	08/01/2006
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-182-02	1 in 1 CARTON	08/01/2006	11/30/2017
2		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49967-182-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	08/01/2006	11/30/2017
4	NDC: 49967-182-04	1 in 1 CARTON	08/01/2006
4		18 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 49967-182-05	1 in 1 CARTON	08/01/2006
5		20 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 not final	part352	08/01/2006

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Sicos et Cie		276993581	manufacture(49967-182)