SPL v2
SPL
SPL Set ID 2b6140cf-7e34-1658-e063-6394a90a3271
Route
TOPICAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (2.5 g) Titanium Dioxide (1.53 g) Octocrylene (4 g) Zinc Oxide (8.73 g)
Inactive Ingredients
Dicaprylyl Carbonate Nutmeg Orange Terpenes Dipropylene Glycol Glycerin Ci 77491 Isohexadecane Magnesium Sulfate Aluminum Monostearate Alumina Ethylhexylglycerin Stearyl Glycyrrhetinate Glyceryl Caprylate Peg-30 Dipolyhydroxystearate Triethoxycaprylylsilane Mica Ci 77492 Tocopherol 1,2-hexanediol Hydroxycitronellal Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Ci 77499 Disteardimonium Hectorite Hexyl Laurate Water Cyclopentasiloxane Diphenylsiloxy Phenyl Trimethicone Chrysin Sorbitan Olivate Caprylic/capric Triglyceride Panthenol Camellia Sinensis Leaf Linalool Moringa Oleifera Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-25
Description

Octisalate 2.5% Octocrylene 4% Titanium Dioxide 1.53% Zinc Oxide 8.73%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Dosage and Administration

If swallowed, get medical help or contact a Poison Control Center right away.

Description

Octisalate 2.5% Octocrylene 4% Titanium Dioxide 1.53% Zinc Oxide 8.73%

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 51945-4

Warning

For external use only.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply at least every 2 hours
  • use a water resistant sunscree nif swimming or sweating

  • 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.-2p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use

Do not use on damaged or broken skin.

Questions?

1-866-993-4709

When Using

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

Other Information
  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics
Active Ingredients

Octisalate 2.5%

Octocrylene 4%

Titanium Dioxide 1.53%

Zinc Oxide 8.73%

Inactive Ingredients

WATER, DICAPRYLYL CARBONATE, HEXYL LAURATE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, GLYCERIN, CYCLOPENTASILOXANE, ISOHEXADECANE, DISTEARDIMONIUM HECTORITE, PANTHENOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, ALUMINA, MICA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, IRON OXIDES(CI 77492), MYRISTICA FRAGRANS (NUTMEG) EXTRACT, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYCITRONELLAL, LIMONENE, LINALOOL

Stop Use and Ask A Doctor

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children

Keep out of reach of children.

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
Dosage and Administration (34068-7)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warning

For external use only.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply at least every 2 hours
  • use a water resistant sunscree nif swimming or sweating

  • 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.-2p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use (Do not use)

Do not use on damaged or broken skin.

Questions?

1-866-993-4709

When Using

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

Other Information
  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics
Active Ingredients

Octisalate 2.5%

Octocrylene 4%

Titanium Dioxide 1.53%

Zinc Oxide 8.73%

Inactive Ingredients

WATER, DICAPRYLYL CARBONATE, HEXYL LAURATE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, GLYCERIN, CYCLOPENTASILOXANE, ISOHEXADECANE, DISTEARDIMONIUM HECTORITE, PANTHENOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, ALUMINA, MICA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, IRON OXIDES(CI 77492), MYRISTICA FRAGRANS (NUTMEG) EXTRACT, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYCITRONELLAL, LIMONENE, LINALOOL

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.964167 · Updated: 2026-03-14T23:08:04.646392