Label: DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-133-01, 75936-133-02, 75936-133-03, 75936-133-04, view more75936-133-05, 75936-133-06 - Packager: Taylor James, LTD
- 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 January 23, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ISODODECANE (UNII: A8289P68Y2) PEPPERMINT OIL (UNII: AV092KU4JH) SPEARMINT OIL (UNII: C3M81465G5) ROSEMARY OIL (UNII: 8LGU7VM393) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-133-02 1 in 1 BOX 01/09/2015 1 NDC:75936-133-01 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:75936-133-04 1 in 1 BOX 01/09/2015 2 NDC:75936-133-03 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 3 NDC:75936-133-06 1 in 1 BOX 01/09/2015 3 NDC:75936-133-05 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/09/2015 Labeler - Taylor James, LTD (033381850) Registrant - Taylor James, LTD (033381850) Establishment Name Address ID/FEI Business Operations Bell Pharmaceuticals 140653770 manufacture(75936-133)