SPL v1
SPL
SPL Set ID 4ebd7db8-7e6c-46ed-9d0c-6f9f81ea65fe
Route
TOPICAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (8 g) Ethylhexyl Salicylate (5 g) Zinc Oxide (4.9 g)
Inactive Ingredients
Ethylhexylglycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Glycerin Polyhydroxystearic Acid Stearate Dimethicone Phenyl Trimethicone Phenoxyethanol Boron Nitride Ferric Oxide Yellow Titanium Dioxide Triethoxycaprylylsilane Silica Propylene Carbonate Medium-chain Triglycerides Alkyl (c12-15) Benzoate Caprylyl Methicone Dimethicone Crosspolymer Methicone (20 Cst) Sodium Hyaluronate Water Di-ppg-3 Myristyl Ether Adipate Disteardimonium Hectorite .alpha.-tocopherol Acetate Ferric Oxide Red Ferrosoferric Oxide Sodium Chloride Silica Dimethyl Silylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01
Description

Active Ingredients Homosalate 8% Octisalate 5% Zinc Oxide 4.9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Active Ingredients Homosalate 8% Octisalate 5% Zinc Oxide 4.9%

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
Section 50565-1

Section 55106-9

Active Ingredients

Homosalate 8%

Octisalate 5%

Zinc Oxide 4.9%

Warnings

For external use only

Do not us eon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

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

Questions ?

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

Product Label

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

Structured Label Content

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
Section 50565-1 (50565-1)

Section 55106-9 (55106-9)

Active Ingredients

Homosalate 8%

Octisalate 5%

Zinc Oxide 4.9%

Purpose

Sunscreen

Warnings

For external use only

Do not us eon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

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

Questions ?

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

Product Label (Product label)

Other Information (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.950598 · Updated: 2026-03-14T23:07:47.363489