GUCCI FACE LUSTROUS GLOW FOUNDATION  BROADSPECTRUM SPF 25 (ALL SHADES)- octinoxate and titanium dioxide lotion 
Procter & Gamble Manufacturing Company

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.

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Gucci Face Lustrous Glow Foundation
Broadspectrum SPF 25 (all shades)

Drug Facts

Active ingredientsPurpose
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?

1-866-607-0858

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.

Principal Display Panel - 30 ml Bottle Carton
GUCCI FACE LUSTROUS GLOW FOUNDATION   BROADSPECTRUM SPF 25 (ALL SHADES)
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-796
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.49 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.52 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-796-301 in 1 CARTON05/26/201406/01/2018
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:37000-796-151 in 1 CARTON05/26/201406/01/2018
215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:37000-796-080.8 mL in 1 POUCH; Type 0: Not a Combination Product05/26/201406/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/26/201406/01/2018
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
Nihon Kolmar Co., Ltd717820687MANUFACTURE(37000-796)
Establishment
NameAddressID/FEIBusiness Operations
Kanae Co., Ltd.718300866PACK(37000-796)

Revised: 5/2016
Document Id: f867bf9b-205c-4885-b56f-0c764856f8c5
Set id: 371d66bd-f666-4f72-b656-e1b097e21e69
Version: 3
Effective Time: 20160524
 
Procter & Gamble Manufacturing Company