FUTURIST SKIN TINT SERUM- octinoxate,octisalate,zinc oxide cream

FUTURIST SKIN TINT SERUM by

Drug Labeling and Warnings

FUTURIST SKIN TINT SERUM by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., PALC, Whitman Laboratories Ltd., Estee Lauder N.V., NORTHTEC INC, PADC 1, The Estee Lauder Inc, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 6.7%
Octisalate 4.5%

Zinc Oxide 6.8%

Purpose

Sunscreen

USE

helps prevent sunburn

WARNINGS

For External Use Only

on damaged or broken skin

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

ESTEE LAUDER
Futurist Skin Tint Serum with Botanical Oil Infusion Broad Spectrum SPF 20

1 FL. OZ. LIQ./30ml

INGREDIENTS AND APPEARANCE

FUTURIST SKIN TINT SERUM 
octinoxate,octisalate,zinc oxide cream

Product 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)