Label: SUNTINTS LIQUID LIP BALM SPF 20- octinoxate, octisalate, avobenzone, homosalate, octocrylene lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0034-1, 40046-0034-2 - Packager: MAKEUP ART COSMETICS
- 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
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL [] [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNTINTS LIQUID LIP BALM SPF 20
octinoxate, octisalate, avobenzone, homosalate, octocrylene lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.9 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength OCTYLDODECANOL (UNII: 461N1O614Y) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) CALCIUM ALUMINOSILICATE (UNII: 3L00JH8411) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STANNIC OXIDE (UNII: KM7N50LOS6) LINOLEIC ACID (UNII: 9KJL21T0QJ) VANILLIN (UNII: CHI530446X) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) COCHINEAL (UNII: TZ8Z31B35M) D&C RED NO. 6 (UNII: 481744AI4O) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 30 (UNII: 2S42T2808B) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0034-1 1 in 1 CARTON 1 NDC:40046-0034-2 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/01/2009 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Inc 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Keystone 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Bristol 959338336 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 943871157 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. 205952385 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 244669714 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 Centre 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture 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 Pennsylvania Logistics Center (PALC) 078364654 repack, relabel
