Label: FUTURIST SKIN TINT SERUM- octinoxate,octisalate,zinc oxide cream
- NDC Code(s): 11559-063-01
- Packager: ESTEE LAUDER INC
- 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 October 3, 2023
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- Active ingredients
- Purpose
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- WARNINGS
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Directions
Directions For sunscreen use: • apply liberally and evenly 15 minutes before sun exposure • reapply at least every two hours • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • children under 6 months of age: ask a doctor
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Inactive Ingredients
WATER\AQUA\EAU [] TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE [] GLYCERIN [] BUTYLENE GLYCOL [] BUTYLOCTYL SALICYLATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] SILICA [] POLYGLYCERYL-10 OLEATE [] BENTONITE [] SACCHARIDE ISOMERATE [] TOCOPHERYL ACETATE [] ACETYL GLUCOSAMINE [] LIMNANTHES ALBA (MEADOWFOAM) SEED OIL [] GLYCERYL HYDROGENATED ROSINATE [] ROSA CANINA (ROSE) FRUIT OIL [] TRAMETES VERSICOLOR EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] GLYCINE SOJA (SOYBEAN) OIL [] PROPYLENE GLYCOL DICAPRATE [] HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT [] GLYCINE SOJA (SOYBEAN) SEED EXTRACT [] HORDEUM VULGARE EXTRACT\EXTRAIT D'ORGE [] CALENDULA OFFICINALIS FLOWER EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] CAPRYLYL GLYCOL [] CHOLESTEROL [] SODIUM STEAROYL GLUTAMATE [] ALGIN [] XANTHAN GUM [] SODIUM CHLORIDE [] ALUMINUM HYDROXIDE [] POLYHYDROXYSTEARIC ACID [] BHT [] CITRIC ACID [] SODIUM CITRATE [] POTASSIUM SORBATE [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491) [] IRON OXIDES (CI 77492) [] IRON OXIDES (CI 77499)] <ILN51379>
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INGREDIENTS AND APPEARANCE
FUTURIST SKIN TINT SERUM
octinoxate,octisalate,zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 68 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ) GLYCERYL ROSINATE (UNII: SD112V492J) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENTONITE (UNII: A3N5ZCN45C) SODIUM ALGINATE (UNII: C269C4G2ZQ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) N-ACETYLGLUCOSAMINE (UNII: V956696549) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CUCUMBER (UNII: YY7C30VXJT) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SOYBEAN (UNII: L7HT8F1ZOD) HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SACCHARIDE ISOMERATE (UNII: W8K377W98I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SOYBEAN OIL (UNII: 241ATL177A) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) SUNFLOWER SEED (UNII: R9N3379M4Z) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM CITRATE (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-063-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/31/2022 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(11559-063) , label(11559-063) , pack(11559-063)
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