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wet n wild megashield

Dosage form: lipstick
Ingredients: OCTINOXATE 7.5g in 100g, OXYBENZONE 2g in 100g
Labeler: Markwins Beauty Products, Inc
NDC Code: 12027-100

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.

Active Ingredients
Octinoxate 7.5%
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
  • 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 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)

Package Label

WET N WILD  MEGASHIELD
octinoxate oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERESIN 
OCTYLDODECANOL 
TRIDECYL STEARATE 
PROPYLHEPTYL CAPRYLATE 
MEDIUM-CHAIN TRIGLYCERIDES 
MICROCRYSTALLINE WAX 
TRIDECYL TRIMELLITATE 
CAPRYLYL GLYCOL 
SORBIC ACID 
RICE GERM OIL  
AVOCADO OIL  
ALPHA-TOCOPHEROL ACETATE 
ALUMINUM OXIDE 
STEARIC ACID 
COCHINEAL 
FERRIC OXIDE RED 
MICA 
D&C RED NO. 7 
D&C RED NO. 28 
D&C RED NO. 30 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:12027-100-103.1 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/FEIOperations
Markwins International Corp.544845621manufacture

Revised: 11/2011
Document Id: 5e6388f9-b66f-422b-b90e-5529dae7c68e
Set id: f277e861-db70-4489-9d7f-d1cab95ac3b8
Version: 1
Effective Time: 20111113
 
Markwins Beauty Products, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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