Wet N Wild Ultimate Sheer (Octinoxate Oxybenzone ) Liquid [Markwins Beauty Products, Inc ] -

WET N WILD ULTIMATE SHEER (OCTINOXATE OXYBENZONE ) LIQUID [MARKWINS BEAUTY PRODUCTS, INC ]
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NDC	12027-104-01
Set ID	eacaab57-0206-419a-9520-cf8b4adba8f8
Category	HUMAN OTC DRUG LABEL
Packager	Markwins Beauty Products, Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

Active Ingredients
Octinoxate 6%
Oxybenzone 2%
INDICATIONS & USAGE

Use• Helps prevent sunburn
WARNINGS

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 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

Stop use and ask a doctor
if rash occurs
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE

Directions • 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
INACTIVE INGREDIENT

Inactive Ingredients/Ingredients inactifsWater/Eau, Butylene Glycol, Isopropyl Myristate, Isododecane, Glyceryl Stearate SE, Triethanolamine, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Talc, Stearic Acid, Sorbitan Sesquioleate, Triacontanyl PVP, Cetyl Palmitate, Alumina, Xanthan Gum, Acrylates Copolymer, Tridecyl Trimellitate, Chlorphenesin, Tocopheryl Acetate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Dipotassium Glycyrrhizate, Disodium EDTA, Stearyl Glycyrrhetinate, Sodium Hyaluronate, Methylisothiazolinone
(MAY CONTAIN/PEUT CONTENIR): Iron Oxides/CI 77491, CI 77492, CI 77499, Titanium Dioxide/CI 77891, Ultramarines/CI 77007 77891, Yellow 6 Lake/CI 15985, Yellow 10 Lake/CI 47005, Zinc Oxide/CI 77947)
PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

WET N WILD ULTIMATE SHEER
octinoxate oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12027-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mL in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODODECANE (UNII: A8289P68Y2)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
TRIDECYL STEARATE (UNII: A8OE252M6L)
TALC (UNII: 7SEV7J4R1U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12027-104-01	29.6 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/01/2011

Labeler - Markwins Beauty Products, Inc (135407760)

Name	Address	ID/FEI	Business Operations
Establishment
Markwins International Corp.		544845621	manufacture

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Medic

WET N WILD ULTIMATE SHEER (OCTINOXATE OXYBENZONE ) LIQUID [MARKWINS BEAUTY PRODUCTS, INC ]

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