RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 -SPICE- octinoxate, zinc oxide liquid

Radiance Foundation Broad Spectrum SPF 20 -Spice by

Drug Labeling and Warnings

Radiance Foundation Broad Spectrum SPF 20 -Spice 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]

Active ingredients

Octinoxate 3%

Zinc Oxide 6.8%

Purpose

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

When using this product 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 swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Other information

• protect this product from excessive heat and direct sun

Directions

shake well
apply liberally and evenly 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: 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:

     o limit time in the sun, especially from 10 a.m.-2 p.m.
     o wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients.

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Hydroxypropylcocoate PEG-8 Dimethicone, Petroleum Distillates, Phenyl Trimethicone, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Squalane, Caprylyl Methicone, C10-11 Isoalkane, Boron Nitride, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Phenoxyethanol, Dimethicone, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Carbonate, Polyhydroxystearic Acid, Oryza Sativa (Rice) Bran Extract, Tocopheryl Acetate, Panthenol, Royal Jelly Powder, Biosaccharide Gum-4, Smithsonite Extract, Ethylhexylglycerin, Withania Somnifera Extract, Laureth-3, Laureth-25, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Chondrus Crispus Extract, Nelumbo Nucifera Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491/CI 77492/CI 77499)

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Product label

INGREDIENTS AND APPEARANCE

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 -SPICE 
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE, UNSPECIFIED (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)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
C10-11 ISOPARAFFIN (UNII: UQ7SPY0IRF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAURETH-3 (UNII: F32E4CB0UJ)
LAURETH-25 (UNII: RPD53041LR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-733-01	1 in 1 CARTON	01/01/2026
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2026

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra cosmetics international, Inc (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-733)