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aloevella

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 5g in 100g, ZINC OXIDE 15g in 100g
Labeler: Ojas Enterprises LLC
NDC Code: 55115-2041

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 ingredients

Titanium dioxide 5%

Zinc Oxide 15%

purpose

Sunscreen

Uses 

• Helps prevent sunburn

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase

your risk of skin cancer and early skin aging.This product has been

shown only to prevent sunburn,not skin cancer or early 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:

   • after 40 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

• children under 6 months: Ask a doctor

Inactive ingredients

water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid,

Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract,

fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl

stearate, Xanthan gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-866-855-9006

   

ALOEVELLA 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55115-2041
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALMOND OIL 
SESAME OIL 
SOYBEAN OIL 
JOJOBA OIL 
CETEARYL OLIVATE 
SORBITAN OLIVATE 
STEARIC ACID 
ALOE VERA LEAF 
ALPHA-TOCOPHEROL 
SODIUM BENZOATE 
CETYL ALCOHOL 
WHEAT GERM OIL 
DEXPANTHENOL 
OLEA EUROPAEA LEAF 
CARROT 
GREEN TEA LEAF 
LICORICE 
AZADIRACHTA INDICA FLOWER 
CUCUMBER 
GLYCERYL MONOSTEARATE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:55115-2041-1200 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/14/2011
Labeler - Ojas Enterprises LLC (968626502)
Establishment
NameAddressID/FEIOperations
Illban Remedies Private Limited915784131manufacture

Revised: 12/2011
 
Ojas Enterprises LLC

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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