GUCCI FACE LUSTROUS GLOW FOUNDATION BROADSPECTRUM SPF 25 (ALL SHADES)- octinoxate and titanium dioxide lotion

Gucci Face Lustrous Glow Foundation by

Drug Labeling and Warnings

Gucci Face Lustrous Glow Foundation by is a Otc medication manufactured, distributed, or labeled by Noxell Corporation, Coty US LLC, Nihon Kolmar Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 3.49%	Sunscreen
TITANIUM DIOXIDE 2.52%	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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use 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 sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, diphenylsiloxy phenyl trimethicone, butylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, triethylhexanoin, talc, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, sodium chloride, tocopherol, tribehenin, vinyl dimethicone/methicone silsesquioxane crosspolymer, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, phytosteryl/octyldodecyl lauroyl glutamate, synthetic fluorphlogopite, aluminum hydroxide, dimethicone, trimethylsiloxysilicate, hydrated silica, hydrogen dimethicone, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, methylparaben, sodium benzoate, propylparaben, fragrance, titanium dioxide, iron oxides

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

GUCCI

GUCCI FACE

LUSTROUS
GLOW FOUNDATION
WITH SUNSCREEN

SPF 25
BROAD SPECTRUM

30 ml / 1.0 FL. OZ.

INGREDIENTS AND APPEARANCE

GUCCI FACE LUSTROUS GLOW FOUNDATION   BROADSPECTRUM SPF 25 (ALL SHADES)
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22700-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.49 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.52 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
TALC (UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22700-002-30	1 in 1 CARTON	06/01/2016
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 22700-002-13	1 in 1 CARTON	06/01/2016	03/31/2018
2		13 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 22700-002-08	1 in 1 PACKAGE	06/01/2016	03/31/2018
3		0.8 mL in 1 POUCH; 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	06/01/2016

Labeler - Noxell Corporation (003082997)

Registrant - Coty US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Nihon Kolmar Co., Ltd		717820687	manufacture(22700-002)