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

Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 by

Drug Labeling and Warnings

Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Fresh, Inc., Parfums Christian Dior. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Fresh Sugar Tulip Tinted Lip Treatment Sunscreen 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.

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, Tocopherol, Ascorbyl Palmitate, CI 15850 (Red 7 Lake), CI 19140 (Yellow 5 Lake), CI 15850 (Red 6), CI 77491 (Iron Oxides), Ammonium Glycyrrhizate, CI 77891 (Titanium Dioxide), Polyglyceryl-3 Polyricinoleate, Vanillin, BHT, Propyl Gallate, Aluminum Hydroxide, CI 42090 (Blue 1 Lake), Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol (07624/Z)

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)

Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 4.3g (

42406-006-00)

INGREDIENTS AND APPEARANCE

FRESH SUGAR TULIP TINTED LIP TREATMENT SUNSCREEN SPF 15 
avobenzone, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-006
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
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
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 TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
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)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-006-00	1 in 1 CARTON	01/09/2014
1		4.3 g in 1 TUBE; 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	01/09/2014

Labeler - Fresh, Inc. (021403729)

Establishment
Name	Address	ID/FEI	Business Operations
Parfums Christian Dior		396393746	manufacture(42406-006)