FDA.reportPublic FDA data

Sable Long Wear Makeup

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:33

Label at a glance#

ProductSable Long Wear Makeup Broad Spectrum SPF 20
Active ingredientOCTISALATE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active

Ingredients          Purpose

Octisalate 3% ...... Sunscreen

Zinc Oxide 6.82% .... Sunscree

OTC - PURPOSE SECTION

Uses

  • helps prevent suburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor
  • 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 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Water/Aqua, Triethoxycaprylylsilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Triemthicone, C12-15 Alkyl Benzoate, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane, Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymehtylsilsesquioxane, Lentinus Edodes (shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extact, Chondrus Crispus (Carrageenan) Extract [ May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA

Long Wear Makeup

Broad Spectrum SPF 20

30 ml / 1 FL oz (us)

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-337-022022-01-28C16284748780-1d6a99b39-c399-a426-e053-dadaa90af4c2Sable - Long Wear Makeup Broad Spectrum SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-337-01Sable Long Wear MakeupBroad Spectrum SPF 2030 mL in 1 TUBECREAM303
68828-337-02Sable Long Wear MakeupBroad Spectrum SPF 201 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-337SABLE LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 (OCTISALATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]3Legacy NDC, 2 package rows20200623_41bffbdc-6fac-4b23-8c02-131bd1dfc558.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-33768828-337-01, 68828-337-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOMETHICONENMQ347994ZIACT
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE8TE0BZU36SIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DI-PPG-3 MYRISTYL ETHER ADIPATET32481VTXWIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
SQUALANEGW89575KF9IACT
BORON NITRIDE2U4T60A6YDIACT
ALOE VERA LEAFZY81Z83H0XIACT
DMDM HYDANTOINBYR0546TOWIACT
ICODEXTRIN2NX48Z0A9GIACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-4 LAURATEAYF4VM3N1ZIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
LENTINULA EDODES MYCELIUMCU2S39TB8OIACT
SWEET POTATOM9WGG9Z9GKIACT
CENTELLA ASIATICA7M867G6T1UIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8b44f5e-bd73-80d3-e053-2995a90aa54241bffbdc-6fac-4b23-8c02-131bd1dfc5582020-06-22WarningsExact identifier
spl id: a8b44f5e-bd73-80d3-e053-2995a90aa542
spl set id: 41bffbdc-6fac-4b23-8c02-131bd1dfc558

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.