Label: COVER YOUR MOUTH SPF 8 LIP PROTECTOR- titanium dioxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-575-01 - Packager: ORIGINS NATURAL RESOURCES INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 27, 2011
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COVER YOUR MOUTH SPF 8 LIP PROTECTOR
titanium dioxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.8 g in 100 g Inactive Ingredients Ingredient Name Strength CANOLA OIL (UNII: 331KBJ17RK) WHITE WAX (UNII: 7G1J5DA97F) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PEPPERMINT OIL (UNII: AV092KU4JH) COCONUT OIL (UNII: Q9L0O73W7L) VANILLA (UNII: Q74T35078H) LAUROYL LYSINE (UNII: 113171Q70B) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ALUMINUM STEARATE (UNII: U6XF9NP8HM) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-575-01 4.5 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/1999 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations PRIVALE LABEL SELECT LTD 005415463 manufacture
