JAFRA BEAUTY ADVANCED SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16- homosalate, octisalate, zinc oxide liquid

JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16 by

Drug Labeling and Warnings

JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16 by is a Otc medication manufactured, distributed, or labeled by Distribuidora Comercial Jafra, S.A. de C.V., Jafra Cosmetics International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 8%

Octisalate 5%

Zinc Oxide 4.9%

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 useon damaged or broken skin

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

Stop use and ask a doctorifrash occurs

KEEP OUT OF REACH OF CHILDREN

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

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:

        limit time in the sun, especially from 10 a.m. – 2 p.m.

        wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Phenyl Trimethicone, Glycerin, C12-15 Alkyl Benzoate, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, Phenyl Dimethicone, Petroleum Distillates, Sodium Chloride, Silica, Phenoxyethanol, Dimethicone Crosspolymer, Boron Nitride, Disteardimonium Hectorite, Triethoxycaprylylsilane, Propylene Carbonate, Polyhydroxystearic Acid, Ethylhexylglycerin, Tocopheryl Acetate, Silica Dimethyl Silylate, Methicone, Sodium Hyaluronate, Iron Oxides, Titanium Dioxide

Questions ?

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

Product label

INGREDIENTS AND APPEARANCE

JAFRA BEAUTY ADVANCED SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16 
homosalate, octisalate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILICA (UNII: ETJ7Z6XBU4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-313-01	1 in 1 CARTON	03/01/2025
1		35 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	03/01/2025

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(68828-313)