WET N WILD MEGASHIELD- octinoxate oxybenzone lipstick

wet n wild by

Drug Labeling and Warnings

wet n wild by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Products, Inc , Markwins International Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Octinoxate 7.5%
Oxybenzone 2%

PURPOSE

Purpose: Sunscreen

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.

DOSAGE & ADMINISTRATION

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: Ozokerite, Pentaerythrityl Tetraisostearate, Octyldodecanol, Bis-Diglyceryl Polyacyladipate-2, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Propylheptyl Caprylate, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Microcrystalline Wax/Cire microcristalline, Polysilicone-6, Tridecyl Trimellitate, Caprylyl Glycol, Sorbic Acid, Oryza Sativa (Rice) Germ Oil, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Alumina, Stearic Acid
(MAY CONTAIN/PEUT CONTENIR): Carmine/CI 75470, Iron Oxides/CI 77491, CI 77492, CI 77499, Mica, Red 7 Lake/CI 15850, Red 28 Lake/CI 45410, Red 30 Lake/CI 73360, Titanium Dioxide/CI 77891, Yellow 5 Lake/CI 19140, Yellow 6 Lake/CI 15985, Zinc Oxide/CI 77947)

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

WET N WILD  MEGASHIELD
octinoxate oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
OCTYLDODECANOL (UNII: 461N1O614Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
RICE GERM OIL (UNII: D4H5GGS5JF)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCHINEAL (UNII: TZ8Z31B35M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 30 (UNII: 2S42T2808B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-100-10	3.1 g in 1 TUBE

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

Labeler - Markwins Beauty Products, Inc (135407760)

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