SPL v1
SPL
SPL Set ID 8f4b5e0a-4578-4af3-b7d9-a19d4eb732e7
Route
TOPICAL
Published
Effective Date 2026-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.25 g) Octisalate (4.75 g) Zinc Oxide (6.75 g)
Inactive Ingredients
Water Isododecane Trimethylsiloxysilicate (m/q 0.6-0.8) C13-14 Isoparaffin Hydroxypropylcocoate Peg-8 Dimethicone Soybean Lecithin Disteardimonium Hectorite Alkyl (c12-15) Benzoate Silicon Dioxide Glycerin Sodium Chloride Niacinamide Dimethicone, Unspecified Phenoxyethanol Propylene Carbonate Triethoxycaprylylsilane Dimethicone Crosspolymer (450000 Mpa.s) Silica Dimethyl Silylate Methicone (20 Cst) Titanium Dioxide Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-01
Description

Homosalate 4.25%                             Sunscreen Octisalate 4.75%                                Sunscreen Zinc Oxide 6.75%                               Sunscreen

Purpose

Homosalate 4.25%                             Sunscreen Octisalate 4.75%                                Sunscreen Zinc Oxide 6.75%                               Sunscreen

Medication Information

Purpose

Homosalate 4.25%                             Sunscreen Octisalate 4.75%                                Sunscreen Zinc Oxide 6.75%                               Sunscreen

Description

Homosalate 4.25%                             Sunscreen Octisalate 4.75%                                Sunscreen Zinc Oxide 6.75%                               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
Section 50565-1

Section 55105-1

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 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 before use
  • 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, Isododecane, Trimethylsiloxysilicate, Petroleum Distillates, Hydroxypropylcocoate PEG-8 Dimethicone, Lecithin, Disteardimonium Hectorite, C12-15 Alkyl Benzoate, Silica, Glycerin, Sodium Chloride, Niacinamide, Dimethicone, Phenoxyethanol, Propylene Carbonate, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Silica Dimethyl Silylate, Methicone, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499

Active Ingredients                            Purpose    

Homosalate 4.25%                             Sunscreen

Octisalate 4.75%                                Sunscreen

Zinc Oxide 6.75%                               Sunscreen

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 55105-1 (55105-1)

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 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 before use
  • 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 (Inactive ingredients)

Water, Isododecane, Trimethylsiloxysilicate, Petroleum Distillates, Hydroxypropylcocoate PEG-8 Dimethicone, Lecithin, Disteardimonium Hectorite, C12-15 Alkyl Benzoate, Silica, Glycerin, Sodium Chloride, Niacinamide, Dimethicone, Phenoxyethanol, Propylene Carbonate, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Silica Dimethyl Silylate, Methicone, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499

Active Ingredients                            Purpose     (Active ingredients                            Purpose    )

Homosalate 4.25%                             Sunscreen

Octisalate 4.75%                                Sunscreen

Zinc Oxide 6.75%                               Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.956230 · Updated: 2026-03-14T23:12:42.073607