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

WET N WILD ULTIMATE MATCH (OCTINOXATE OXYBENZONE ) LIQUID [MARKWINS BEAUTY PRODUCTS, INC ]
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NDC	12027-102-29
Set ID	4a5e9b5d-3b58-4483-bdfe-27e73870c071
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 inactifs Water/Eau, Tridecyl Trimellitate, Talc, Isopropyl Myristate, Isododecane, Butylene Glycol, Glycerin, Glyceryl Stearate SE, Sorbitan Sesquioleate, Triacontanyl PVP, Triethanolamine, Stearic Acid, Cetyl Palmitate, Alumina, Sodium Laureth Sulfate, Chlorphenesin, Hydroxyethylcellulose, Acrylates Copolymer, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Disodium EDTA, Xanthan Gum, Caprylic/Capric Triglyceride, Stearyl Glycyrrhetinate, Laminaria Ochroleuca Extract, 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 MATCH
octinoxate oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12027-102
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)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
TALC (UNII: 7SEV7J4R1U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISODIUM GLYCYRRHIZATE (UNII: L8Q0US0J7V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
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:12027-102-29	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 MATCH (OCTINOXATE OXYBENZONE ) LIQUID [MARKWINS BEAUTY PRODUCTS, INC ]

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