Label: LOVEA- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76363-029-11 - Packager: Laboratoires Biocos
- 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 April 26, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Drug Facts
Active ingredients Purpose
Titanium dioxide (12,1%) ........................................................................Sunscreen
Use
• Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides
high protection against sunburn
Warnings
For external use only. When using this product keep out of eyes. Rinse with water
to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep
out of the reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.
Directions
• Apply generously and evenly to all areas 15 minutes before sun exposure • Spray on
hands to apply to face • Reapply at frequent intervals and after swimming, sweating
or towel drying • Ask a doctor before use on children under six months of age
Other information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens
may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive ingredients
DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE,
COCO-CAPRYLATE/CAPRATE, ALCOHOL*, ARGANIA SPINOSA KERNEL OIL*, ALUMINIUM HYDROXIDE,
STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, PARFUM (FRAGRANCE), COCOS NUCIFERA
(COCONUT) OIL, GARDENIA TAHITENSIS FLOWER, OLEYL ALCOHOL, ZANTHOXYLUM ALATUM FRUIT
EXTRACT. *Ingredients from organic farming
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOVEA
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76363-029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM dioxide - UNII:15FIX9V2JP) Titanium dioxide 12.1 g in 100 g Inactive Ingredients Ingredient Name Strength Dicaprylyl carbonate (UNII: 609A3V1SUA) Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8) Stearic Acid (UNII: 4ELV7Z65AP) Aluminum hydroxide (UNII: 5QB0T2IUN0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Coco-caprylate (UNII: 4828G836N6) Coco-caprylate/caprate (UNII: 8D9H4QU99H) Alcohol (UNII: 3K9958V90M) ARGAN OIL (UNII: 4V59G5UW9X) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) COCONUT OIL (UNII: Q9L0O73W7L) GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) ZANTHOXYLUM ARMATUM VAR. ARMATUM FRUIT (UNII: ER3FV125H7) oleyl alcohol (UNII: 172F2WN8DV) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) P-METHYL ANISOLE (UNII: 10FAI0OR9W) BENZYL BENZOATE (UNII: N863NB338G) METHYL BENZOATE (UNII: 6618K1VJ9T) BENZYL SALICYLATE (UNII: WAO5MNK9TU) FARNESOL (UNII: EB41QIU6JL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76363-029-11 128 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/26/2012 Labeler - Laboratoires Biocos (774179378) Registrant - Laboratoires Biocos (774179378) Establishment Name Address ID/FEI Business Operations Laboratoires Biocos 774179378 manufacture
