Radiance Foundation Broad Spectrum SPF 20 - Fair by JAFRA COSMETICS INTERNATIONAL / Distribuidora Comercial Jafra, S.A. de C.V.

Radiance Foundation Broad Spectrum SPF 20 - Fair by

Drug Labeling and Warnings

Radiance Foundation Broad Spectrum SPF 20 - Fair by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - FAIR- octinoxate, zinc oxide liquid 
JAFRA COSMETICS INTERNATIONAL

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.

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Active ingrdients              Purpose

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

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

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

Warnings

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

  • 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

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, Rosamarinus 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

Protect this product from excessive heat and direct sun

Product label

image description

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - FAIR 
octinoxate, zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68828-729
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SQUALANE (UNII: GW89575KF9)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
ROYAL JELLY (UNII: L497I37F0C)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68828-729-011 in 1 CARTON01/07/202204/28/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/07/202204/28/2023
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-729)

Revised: 5/2023