FDA.reportPublic FDA data

Sable Radiance Foundation Broad Spectrum SPF 20 - Tawny

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V
Effective date
2019-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:25

Label at a glance#

ProductSable Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3% .................. Sunscreen

Zinc Oxide 6.8% ................ Sunscreen

OTC - PURPOSE SECTION

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions

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

  • apply liberally 15 minutes befor 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 the this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleev shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Water/Aqua, Titanium Dioxide, Triethoxycaprylysilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Diemthicone, C12-15 Alkyl Benzoate, Phenyl Dimethicone, Phenyl Trimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Di-PPG-3 Myristyl Ether Adipate Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Royal Jelly, Propanediol, Sodium Chloride, DMDM Hydantoin, Dextin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosamarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Biosacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/CI 77491/CI 77492/CI 77499

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA

Royal Jelly

Raidiance Foundation

Broad Spectrum SPF 20

30 ml   1 FL OZ (US)

BoxBox

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
68828-260-022022-01-28C16284748780-1d6a99b39-d19a-a426-e053-dadaa90af4c2Sable- Radiance Foundation Broad Spectrum SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-260-01Sable Radiance Foundation Broad Spectrum SPF 20 - TawnyJAFRA30 mL in 1 TUBECREAM302
68828-260-02Sable Radiance Foundation Broad Spectrum SPF 20 - TawnyJAFRA1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-260SABLE RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - TAWNY JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]2Legacy NDC, 2 package rows20190202_5fd286e2-91bb-4625-884a-9870dbc1f64c.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-26068828-260-01, 68828-260-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOMETHICONENMQ347994ZIACT
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE8TE0BZU36SIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SQUALANEGW89575KF9IACT
DI-PPG-3 MYRISTYL ETHER ADIPATET32481VTXWIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BORON NITRIDE2U4T60A6YDIACT
ROYAL JELLYL497I37F0CIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
DMDM HYDANTOINBYR0546TOWIACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-4 LAURATEAYF4VM3N1ZIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

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
492f155f-fe94-4b75-ab39-db82bd9b54215fd286e2-91bb-4625-884a-9870dbc1f64c2019-02-01WarningsExact identifier
spl id: 492f155f-fe94-4b75-ab39-db82bd9b5421
spl set id: 5fd286e2-91bb-4625-884a-9870dbc1f64c

Reported adverse events (FAERS/openFDA)#

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