ALOEVELLA- titanium dioxide, zinc oxide cream

aloevella by

Drug Labeling and Warnings

aloevella by is a Otc medication manufactured, distributed, or labeled by Ojas Enterprises LLC, Illban Remedies Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

   

INGREDIENTS AND APPEARANCE

ALOEVELLA 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55115-2041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55115-2041-1	200 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/14/2011

Labeler - Ojas Enterprises LLC (968626502)

Establishment
Name	Address	ID/FEI	Business Operations
Illban Remedies Private Limited		915784131	manufacture