NDC | 22700-002-08, 22700-002-13, 22700-002-30 |
Set ID | 44180653-baa1-4178-b6d6-693d484c9b5d |
Category | HUMAN OTC DRUG LABEL |
Packager | Noxell Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
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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
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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?
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
GUCCI FACE LUSTROUS GLOW FOUNDATION BROADSPECTRUM SPF 25 (ALL SHADES)
octinoxate and titanium dioxide lotionProduct 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)