SPL v5
SPL
SPL Set ID 5c0805c7-9b92-4c08-877c-64e720308430
Route
TOPICAL
Published
Effective Date 2025-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3 g) Zinc Oxide (6.8 g)
Inactive Ingredients
Water Titanium Dioxide Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Hydroxypropylcocoate Peg-8 Dimethicone Alkyl (c12-15) Benzoate Phenyl Trimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Squalane Di-ppg-3 Myristyl Ether Adipate Caprylyl Trisiloxane Dimethicone, Unspecified Peg-10 Dimethicone (600 Cst) Disteardimonium Hectorite Boron Nitride Royal Jelly Propanediol Sodium Chloride Rice Bran Rosemary Helianthus Annuus Flowering Top Tocopherol Panthenol .alpha.-tocopherol Acetate Biosaccharide Gum-4 Chondrus Crispus Carrageenan Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Medium-chain Triglycerides Withania Somnifera Flower Nelumbo Nucifera Flower C10-11 Isoparaffin Phenoxyethanol Propylene Carbonate Ethylhexylglycerin Laureth-3 Laureth-25

Identifiers & Packaging

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

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Purpose

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Medication Information

Purpose

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Description

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ 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

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.

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, 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)

Active Ingredients             purpose

Octinoxate 3% .................. Sunscreen

Zinc Oxide 6.8% ................ 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)

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.

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 (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)

Active Ingredients             purpose (Active ingredients             Purpose)

Octinoxate 3% .................. Sunscreen

Zinc Oxide 6.8% ................ Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.536666 · Updated: 2026-03-14T23:12:08.624404