WET N WILD JUICY LIP BALM- octinoxate octocrylene oxybenzone lipstick 
Markwins Beauty Products, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients
Octinoxate 7.5%
Octocrylene 7%
Oxybenzone 2%

Purpose: Sunscreen

Use 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 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

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)

Package Label
image of package label

WET N WILD  JUICY LIP BALM
octinoxate octocrylene oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12027-101-267.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2011
Labeler - Markwins Beauty Products, Inc (135407760)
Establishment
NameAddressID/FEIBusiness Operations
Markwins International Corp.544845621manufacture

Revised: 11/2011
Document Id: f0e754d4-49d2-40d1-b31b-59f3eca75102
Set id: 8ce635b9-4704-4f89-93f2-ed4679842491
Version: 1
Effective Time: 20111113
 
Markwins Beauty Products, Inc