FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS- octinoxate, oxybenzone, titanium dioxide cream

Fresh Peony Brightening UV Shield Sunscreen SPF 50 Plus by

Drug Labeling and Warnings

Fresh Peony Brightening UV Shield Sunscreen SPF 50 Plus 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 Peony Brightening UV Shield Sunscreen SPF 50+

Active Ingredients

Octinoxate 7.49%
Oxybenzone 2.00%
Titanium Dioxide 8.88%

Purpose

Sunscreen

Uses

• 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
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
  

Other Information

Protect this product in container from excessive heat and direct sun

Inactive Ingredients

Aqua (water), C12-15 Alkyl Benzoate, Phenyl Trimethicone, Butylene Glycol, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, CI 77891 (Titanium Dioxide), Isododecane, Diphenylsiloxy Phenyl Trimethicone, Silica, Vinyl Dimethicone/Methicone Silsesqulaxene Crosspolymer, Ascorbyl Glucoside, Aluminum Stearate, Polyhydroxystearic Acid, Magnesium Sulfate, Citrus Limon (Lemon) Peel Oil, Butyrospermum Parkii (Shea) Seedcake Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Suffruticosa Root Extract, Sodium Hyaluronate, Tocopheryl Acetate, Tocopherol, Tromethamine, Mica, Alumina, Sorbitan Sesquioleate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Sodium Citrate, Disteardimonium Hectorite, Caprylyl Glycol, Tetrasodium EDTA, Caprylic/Capric Triglyceride, Sodium Myristoyl Glutamate, Propylene Carbonate, Stearyl Glycyrrhetinate, CI 77492 (Iron Oxides), CI 77491 (Iron Oxides), Aluminum Hydroxide, Citric Acid, BHT, CI 77499 (Iron Oxides), Phenoxyethanol, Limonene, Citral (08302/Z). 12M

Questions or Comments?

Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

Fresh Peony Brightening UV Shield Sunscreen SPF 50+ 30ml (

42406-007-00)

INGREDIENTS AND APPEARANCE

FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS 
octinoxate, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	88.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
LEMON OIL (UNII: I9GRO824LL)
CUCUMBER (UNII: YY7C30VXJT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TROMETHAMINE (UNII: 023C2WHX2V)
MICA (UNII: V8A1AW0880)
ALUMINUM OXIDE (UNII: LMI26O6933)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE SODIUM (UNII: MP1J8420LU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-007-00	1 in 1 CARTON	01/09/2014
1		30 mL in 1 BOTTLE, PUMP; 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
Guerlain S.A.		266623064	manufacture(42406-007)