Homosalate, Octisalate, Zinc Oxide

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International, Inc.
Effective date
2025-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:16

Label at a glance#

ProductJAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure10 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

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 su...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Homosalate 8%

Octisalate 5%

Zinc Oxide 4.9%

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 useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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 ?

OTHER SAFETY INFORMATION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-306-01JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND181 in 1 CARTONLIQUID11
68828-306-01JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND1835 mL in 1 BOTTLELIQUID351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-306JAFRA BEAUTY ADVANCED SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18 (HOMOSALATE, OCTISALATE, ZINC OXIDE) LIQUID [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]1Current NDC, 2 package rows20250302_15eae33b-e8f5-4334-8bf9-fa02ed6ff46d.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-30668828-306-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.15eae33b-e8f5-4334-8bf9-fa02ed6ff46d2025-02-03WarningsExact identifier
ndc (package): 68828-306-01
ndc (product): 68828-306
ndc11 (package): 68828030601
spl id: 2d4296c0-b0e2-02ae-e063-6394a90a9f7b
spl set id: 15eae33b-e8f5-4334-8bf9-fa02ed6ff46d

Reported adverse events (FAERS/openFDA)#

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