Label: SUN-KISSED LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick
KISS AND SHIELD LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick
INSPIRED BY COLOR- octinoxate, octocrylene, octisalate, and oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 75862-015-50, 75862-016-50, 75862-017-50 - Packager: GANZ U.S.A., 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 April 25, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Use
- Warnings
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Inactive ingredients
petrolatum, isopropyl myristate, paraffin, candelilla wax, synthetic beeswax, polyethylene, cetyl alcohol, lanolin, isopropyl lanolate, oleyl alcohol, octyldodecanol, phenyl trimethicone, flavor, tocopheryl acetate, aloe barbadensis leaf extract, glycine soja (soybean) oil, titanium dioxide, methylparaben, propylparaben, silica, saccharin, DEA-oleth-3 phosphate
- PRINCIPAL DISPLAY PANEL - 4 g Box
- PRINCIPAL DISPLAY PANEL - 4 g Box
- PRINCIPAL DISPLAY PANEL - 4 g Box
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INGREDIENTS AND APPEARANCE
SUN-KISSED LIP BALM LEMON LIME SPF30
octinoxate, octocrylene, octisalate, and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-015 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PARAFFIN (UNII: I9O0E3H2ZE) CANDELILLA WAX (UNII: WL0328HX19) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) CETYL ALCOHOL (UNII: 936JST6JCN) LANOLIN (UNII: 7EV65EAW6H) OLEYL ALCOHOL (UNII: 172F2WN8DV) OCTYLDODECANOL (UNII: 461N1O614Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN (UNII: FST467XS7D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-015-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2011 KISS AND SHIELD LIP BALM LEMON LIME SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-016 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PARAFFIN (UNII: I9O0E3H2ZE) CANDELILLA WAX (UNII: WL0328HX19) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) CETYL ALCOHOL (UNII: 936JST6JCN) LANOLIN (UNII: 7EV65EAW6H) OLEYL ALCOHOL (UNII: 172F2WN8DV) OCTYLDODECANOL (UNII: 461N1O614Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN (UNII: FST467XS7D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-016-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2011 INSPIRED BY COLOR LEMON LIME SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-017 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PARAFFIN (UNII: I9O0E3H2ZE) CANDELILLA WAX (UNII: WL0328HX19) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) CETYL ALCOHOL (UNII: 936JST6JCN) LANOLIN (UNII: 7EV65EAW6H) OLEYL ALCOHOL (UNII: 172F2WN8DV) OCTYLDODECANOL (UNII: 461N1O614Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN (UNII: FST467XS7D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-017-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2011 Labeler - GANZ U.S.A., LLC (798785242)
