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Badger Aloe Vera Sunscreen Broad Spectrum SPF 27

Dosage form: lotion
Ingredients: Zinc Oxide 87mL in 100mL, TITANIUM 1.75mL in 100mL
Labeler: Autumn Harp, Inc.
NDC Code: 51514-0233

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.

Drug Facts

Active IngredientActive Ingredient                                                Purpose

Non-nano Zinc Oxide 20% ...                         Sunscreen
Non-nano Titanium Dioxide  1.75%                 Sunscreen  

Uses

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Warnings: For external use only

Do not useDo not use on damaged or broken skin. Stop and ask a doctor if rash occurs.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a poison control  center  right  away.

Directions

For full protection, apply liberally (2mg/cm2 of skin) to all exposed skin. Use a water resistant sunscreen if swimming or sweating. Reapply: At least every 2 hours

Sun Protection Measures

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2pm. Wear long-sleeved shirts, pants, hats, and sunglasses.  For children  under 6 months of age: ask a doctor.

Inactive Ingredients

Inactive Ingredients:  Aloe Barbadensis Leaf Juice, Sucrose Polysoyate, Olea Europaea (Olive) Fruit Oil, Ethyl Palmate, Water, Silica, Sucrose Cocoate, Glycerin, Citrus Medica Limonum Extract, Chondrus Crispus (Carrageenan) Extract, Xanthan Gum, Hydrolyzed Soy Protein.

Label

BADGER ALOE VERA SUNSCREEN   BROAD SPECTRUM SPF 27
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0233
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide87 mL  in 100 mL
TITANIUM (TITANIUM) TITANIUM1.75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
GLYCERIN 
XANTHAN GUM 
CARRAGEENAN 
SUCROSE COCOATE 
SOY PROTEIN 
OLIVE OIL 
Packaging
#Item CodePackage Description
1NDC:51514-0233-187 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/16/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIOperations
Autumn Harp, Inc.064187883manufacture

Revised: 02/2012
 
Autumn Harp, 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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