FRESH SUGAR CHERRY TINTED LIP TREATMENT SPF 15 - avobenzone and octinoxate stick
Fresh, Inc.

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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Fresh Sugar Cherry 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

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

Fresh Sugar Cherry Tinted Lip Treatment SPF 15 4.3g (42406-005-00)

OuterBox

InnerLabel

DrugFacts

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42406-005
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (AVOBENZONE)	AVOBENZONE	2.00 g in 100 g
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.49 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX
RICINUS COMMUNIS SEED
SIMMONDSIA CHINENSIS SEED
OLIVE OIL
GRAPE SEED OIL
CARNAUBA WAX
AVOCADO OIL
MEADOWFOAM SEED OIL
PASSIFLORA INCARNATA SEED OIL
SUCROSE TETRAISOSTEARATE
RIBES NIGRUM SEED OIL
SUNFLOWER OIL
VITAMIN A PALMITATE
ASCORBYL TETRAISOPALMITATE
TOCOPHEROL
ASCORBYL PALMITATE
D&C RED NO. 7
FD&C YELLOW NO. 5
D&C RED NO. 6
FERRIC OXIDE RED
AMMONIUM GLYCYRRHIZATE
TITANIUM DIOXIDE
VANILLIN
BUTYLATED HYDROXYTOLUENE
PROPYL GALLATE
ALUMINUM HYDROXIDE
FD&C BLUE NO. 1
LIMONENE, (+)-
CITRAL
BENZYL ALCOHOL
LINALOOL, (+)-
GERANIOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:42406-005-00	4.3 g in 1 TUBE	None

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	Operations
Parfums Christian Dior		396393746	manufacture

Revised: 11/2012 Fresh, Inc.