Label: ALOEVELLA- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55115-2041-1 - Packager: Ojas Enterprises LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated December 28, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
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INGREDIENTS AND APPEARANCE
ALOEVELLA
titanium dioxide, zinc oxide creamProduct 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
