FRESH SUGAR CORAL TINTED LIP TREATMENT SPF 15- octinoxate, avobenzone stick

Fresh Sugar Coral Tinted Lip Treatment SPF 15 by

Drug Labeling and Warnings

Fresh Sugar Coral Tinted Lip Treatment SPF 15 by is a Otc medication manufactured, distributed, or labeled by Fresh, Inc., Guerlain S.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Octinoxate (Ethylhexyl Methoxycinnamate) 7.49 %
Avobenzone (Butyl Methoxydibenzoylmethane) 2.00 %

OTHER INGREDIENTS:

Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Retinyl Palmitate, Ascorbyl Tetraisopalmitate, Tocopherol, Ascorbyl Palmitate, CI 77492 (Iron Oxides), CI 77891 (Titanium Dioxide), CI 15890 (Red 7 Lake), CI 15850 (Red 6), Ammonium Glycyrrhizate, Polyglyceryl-3 Polyricinoleate, Vanillin, BHT, CI 77499 (Iron Oxides), Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool

Warning:

Avoid contact with the eyes. For external use only.

Keep out of reach of children

Keep out of reach of children

Stop Use

Discontinue use if signs of irritation or rash appear.

To Use:

Apply prior to sun exposure

Purpose

Sunscreen

Description

SPF 15  Fresh® Sugar Coral Tinted Lip Treatment SPF 15 moisturizes, protects, and smoothes the lips while leaving a juicy coral tint, offering sheer coverage or buildable color. It is the perfect partner to our popular Sugar Lip Treatment SPF 15.  H00002484  Fresh Inc NYC 10022 USA London W1U4RD UK www.fresh.com Made in France ©2011

PRINCIPAL DISPLAY PANEL

fresh F21C  Active Ingredients  Octinoxate : 7.49%  Avobenzone : 2%

PRINCIPAL DISPLAY PANEL

TO USE  Apply prior to sun exposure  WARNING  Avoid contact with the eyes. For external use only. Keep out of reach of children. Discontinue use if signs of irritation or rash appear.

PRINCIPAL DISPLAY PANEL

SUGAR CORAL fresh F21C  SUGAR CORAL TINTED LIP TREATMENT  SPF 15 4.3g e 0.15oz  Fresh Inc NYC 10022 USA London W1U4RD UK  www.fresh.com Made in France ©2011  Important: See Leaflet / Voir Notice

PRINCIPAL DISPLAY PANEL

fresh SUGAR CORAL LIP TREATMENT 4.3g e 0.15oz fresh F21C

Fresh Sugar Coral Tinted Lip Treatment SPF 15 4.3g (

42406-002-00)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESH SUGAR CORAL TINTED LIP TREATMENT SPF 15 
octinoxate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.49 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
VANILLIN (UNII: CHI530446X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYL GALLATE (UNII: 8D4SNN7V92)
CITRAL (UNII: T7EU0O9VPP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CASTOR OIL (UNII: D5340Y2I9G)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
SUNFLOWER OIL (UNII: 3W1JG795YI)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-002-00	1 in 1 CARTON	02/08/2012
1		4.3 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/08/2012

Labeler - Fresh, Inc. (021403729)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain S.A		266623064	manufacture(42406-002)