WET N WILD JUICY LIP BALM- octinoxate octocrylene 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%
Octocrylene 7%
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: Pentaerythrityl Tetraisostearate, Bis-Diglyceryl Polyacyladipate-2, Ethylhexyl Isononanoate, Propylheptyl Caprylate, Ozokerite, Tridecyl Trimellitate, Mineral Oil/Huile minérale, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate,  Diisostearyl Malate, Polyethylene, Euphorbia Cerifera (Candelilla) Wax/Cire de candelilla, Beeswax/Cire d’abeille, Ricinus Communis (Castor) Seed Oil, Caprylyl Glycol, Hydrogenated Styrene/Isoprene Copolymer, Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Sorbic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Laminaria Ochroleuca Extract, BHT, Fragrance/Parfum
(MAY CONTAIN/PEUT CONTENIR): Blue 1 Lake/CI 42090, Red 7 Lake/CI 15850, Red 28 Lake/CI 45410, Titanium Dioxide/CI 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  JUICY LIP BALM
octinoxate octocrylene oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-101
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
CERESIN (UNII: Q1LS2UJO3A)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MINERAL OIL (UNII: T5L8T28FGP)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AVOCADO OIL (UNII: 6VNO72PFC1)
SORBIC ACID (UNII: X045WJ989B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-101-26	7.5 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