FDA.reportPublic FDA data

Radiance Foundation Broad Spectrum SPF 20 -Caramel

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Distribuidora Comercial Jafra, S.A. de C.V.
Effective date
2022-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:25

Label at a glance#

ProductRadiance Foundation Broad Spectrum SPF 20 -Caramel
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn 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

Dosage and administration

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 value of 15 or higher and other sun protection measures inclu...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3% 

Zinc Oxide 6.8% 

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • 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

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients.

INACTIVE INGREDIENT SECTION

Water/Aqua, Titanium Dioxide, Triethoxycaprylylsilane, Caprylic Capric Triglyceride,
Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, 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, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/CI 77491/CI 77492/CI 77499

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-73668828-736-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
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
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-4 LAURATEAYF4VM3N1ZIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
faa5a993-bde7-088f-e053-6394a90ac0c0cd33d0a2-9bde-471b-bcd8-72ba817a8af82023-05-01WarningsExact identifier
spl set id: cd33d0a2-9bde-471b-bcd8-72ba817a8af8

Reported adverse events (FAERS/openFDA)#

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