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

Fresh Sugar Berry Tinted Lip Treatment SPF 15 by

Drug Labeling and Warnings

Fresh Sugar Berry 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]

Fresh Sugar Berry Tinted Lip Treatment SPF 15

Active Ingredients

Avobenzone 2.00%
Octinoxate 7.49%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

For sunscreen use:.
▀ Apply liberally 15 minutes before sun exposure
▀ Use a water resistant sunscreen if swimming or sweating
▀ Reapply at least every 2 hours
▀ Children under 6 months: Ask a doctor

Other Information

Protect this product in container from excessive heat and direct sun

Questions or Comments?

Call toll free 1(800)FRESH-20

Monday-Friday (9 a.m. to 5p.m EST)

Inactive 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, Ascorbyl Palmitate, Tocopherol, Ammonium Glycyrrhizate, Polyglyceryl-3 Polyricinoleate, Vanillin, BHT, Propyl Gallate, Aluminum Hydroxide, CI 77891 (Titanium Dioxide), CI 15850 (Red 7 Lake), CI 77492 (Iron Oxides), CI 77491 (Iron Oxides), CI 45410 (Red 28 Lake), CI 42090 (Blue 1 Lake), Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol 06837A

SPL UNCLASSIFIED SECTION

Fresh Inc NYC 10022 USA
London W1U4RD UK
www.fresh.com
Made in France ©2012

Fresh Sugar Berry Tinted Lip Treatment SPF 15 4.3g (

42406-003-00)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
OLIVE OIL (UNII: 6UYK2W1W1E)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
SUCROSE TETRAISOSTEARATE (UNII: FST191693T)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
SUNFLOWER OIL (UNII: 3W1JG795YI)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYL GALLATE (UNII: 8D4SNN7V92)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRAL (UNII: T7EU0O9VPP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-003-00	4.3 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2012

Labeler - Fresh, Inc. (021403729)

Registrant - Fresh, Inc. (021403729)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain S.A		266623064	manufacture(42406-003)