Label: MICKEY SUN SMACKER SPF 24 HOME RUN STAR FRUIT- octinoxate, oxybenzone, padimate o lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 50051-0009-4 - Packager: Bonne Bell LLC
- 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 September 6, 2012
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSES
- USE
- WARNINGS
- Do not use
- Stop use and ask a doctor
- When using this product
- Keep out of the reach of children.
- DIRECTIONS
- Storage and Handling
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INACTIVE INGREDIENTS
RICINUS COMMUNIS (CASTOR) SEED OIL, CETYL ACETATE, BEESWAX (CERA ALBA), EUPHORBIA CERIFERA (CANDELILLA) WAX, FLAVOR/AROMA, POLYBUTENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, ACETYLATED LANOLIN ALCOHOL, SESAMUM INDICUM (SESAME) SEED OIL, ISOPROPYL MYRISTATE, BENZYL BENZOATE, PARAFFIN, POLYESTER-3, TRITICUM VULGARE (WHEAT) GERM OIL, MICA, PROPYLENE GLYCOL, STEARIC ACID, HYDROGENATED SOY GLYCERIDES, PROPYL GALLATE, CITRIC ACID, NEOTAME, CITRAL, LINALOOL, BENZYL ALCOHOL, GERANIOL, METHYL 2-OCTYNOATE, CINNAMAL, EUGENOL, FARNESOL, LIMONENE. MAY CONTAIN (PLUS OR MINUS) TITANIUM DIOXIDE (CI 77891), BLUE 1 LAKE (CI 42090), RED 28 (CI 45410), RED 6 LAKE (CI 15850), RED 22 (CI 45380), YELLOW 5 LAKE (CI 19140), CARMINE (CI 75470).
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INGREDIENTS AND APPEARANCE
MICKEY SUN SMACKER SPF 24 HOME RUN STAR FRUIT
octinoxate, oxybenzone, padimate o lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50051-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 8 g in 100 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) CETYL ACETATE (UNII: 4Q43814HXS) YELLOW WAX (UNII: 2ZA36H0S2V) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) SESAME OIL (UNII: QX10HYY4QV) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BENZYL BENZOATE (UNII: N863NB338G) PARAFFIN (UNII: I9O0E3H2ZE) WHEAT GERM OIL (UNII: 14C97E680P) MICA (UNII: V8A1AW0880) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYL GALLATE (UNII: 8D4SNN7V92) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) NEOTAME (UNII: VJ597D52EX) CITRAL (UNII: T7EU0O9VPP) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL ALCOHOL (UNII: LKG8494WBH) GERANIOL (UNII: L837108USY) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) CINNAMALDEHYDE (UNII: SR60A3XG0F) EUGENOL (UNII: 3T8H1794QW) FARNESOL (UNII: EB41QIU6JL) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 6 (UNII: 481744AI4O) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color Score Shape Size Flavor FRUIT (fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50051-0009-4 4 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/06/2012 Labeler - Bonne Bell LLC (004189809)