ALOEVELLA - titanium dioxide, zinc oxide cream 
Ojas Enterprises LLC

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

product label   

ALOEVELLA 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55115-2041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SESAME OIL (UNII: QX10HYY4QV)  
SOYBEAN OIL (UNII: 241ATL177A)  
JOJOBA OIL (UNII: 724GKU717M)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WHEAT GERM OIL (UNII: 14C97E680P)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
CARROT (UNII: L56Z1JK48B)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LICORICE (UNII: 61ZBX54883)  
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
CUCUMBER (UNII: YY7C30VXJT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Illban Remedies Private Limited915784131manufacture

Revised: 12/2011
Document Id: 271a251e-d256-40f3-8a4a-df9c4a8e485a
Set id: 154c9375-7238-4721-8e0d-6383123b99d0
Version: 3
Effective Time: 20111228
 
Ojas Enterprises LLC