10cde253-26ee-b97d-e063-6394a90a8302

SPL v2
SPL
SPL Set ID 10cde253-26ee-b97d-e063-6394a90a8302
Route
topical
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (100 mg) octisalate (45 mg) homosalate (70 mg) avobenzone (30 mg)
Inactive Ingredients
sodium citrate isododecane p-anisic acid tri(polyglyceryl-3/lauryl) hydrogenated trilinoleate chlorphenesin dimethicone/vinyl dimethicone crosspolymer (soft particle) glycerin phenoxyethanol diethylhexyl 2,6-naphthalate behenyl acrylate polymer biosaccharide gum-2 butyloctyl salicylate magnesium sulfate n-acetylcarnosine pentylene glycol propanediol trisodium ethylenediamine disuccinate tocopherol soybean lecithin aqua

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-04
Description

Avobenzone 3.0%............UV Filter Homosalate 7.0%.............UV Filter Octisalate 4.5%................UV Filter Octocrylene 10.0%...........UV Filter

Medication Information

Warnings and Precautions

Warnings

For External use only

  • Do not use on damaged or broken skin
  • When using this product. Keep it 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
Active Ingredient

Avobenzone 3.0%............UV Filter

Homosalate 7.0%.............UV Filter

Octisalate 4.5%................UV Filter

Octocrylene 10.0%...........UV Filter

Indications and Usage

Directions

  • Shake well before use.
  • Apply to face liberally and evenly15 minutes before sun exposure reapply every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating.
  • for use on children less than 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
Dosage and Administration

Description

Avobenzone 3.0%............UV Filter Homosalate 7.0%.............UV Filter Octisalate 4.5%................UV Filter Octocrylene 10.0%...........UV Filter

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients

Aqua, Behenyl Acrylate Polymer, Biosaccharide Gum-2, Butyloctyl Salicylate, Chlorphenesin, Diethylhexyl 2,6-Naphthalate, Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle), Glycerin, Isododecane, Magnesium Sulfate, N-Acetylcarnosine, p-Anisic Acid, Pentylene Glycol, Phenoxyethanol, Propanediol, Sodium Citrate, Soy Phospholipids, Tocopherol, Tri(Polyglyceryl-3/Lauryl)Hydrogenated Trilinoleate, Trisodium Ethylenediamine Disuccinate.

Section 51945-4

Section 53413-1

Questions?

Visit www.theordinary.com

or call +1 800.513.6088

Section 55105-1

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For External use only

  • Do not use on damaged or broken skin
  • When using this product. Keep it 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
Active Ingredient (55106-9)

Avobenzone 3.0%............UV Filter

Homosalate 7.0%.............UV Filter

Octisalate 4.5%................UV Filter

Octocrylene 10.0%...........UV Filter

Indications and Usage (34067-9)

Directions

  • Shake well before use.
  • Apply to face liberally and evenly15 minutes before sun exposure reapply every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating.
  • for use on children less than 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
Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients

Aqua, Behenyl Acrylate Polymer, Biosaccharide Gum-2, Butyloctyl Salicylate, Chlorphenesin, Diethylhexyl 2,6-Naphthalate, Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle), Glycerin, Isododecane, Magnesium Sulfate, N-Acetylcarnosine, p-Anisic Acid, Pentylene Glycol, Phenoxyethanol, Propanediol, Sodium Citrate, Soy Phospholipids, Tocopherol, Tri(Polyglyceryl-3/Lauryl)Hydrogenated Trilinoleate, Trisodium Ethylenediamine Disuccinate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Visit www.theordinary.com

or call +1 800.513.6088

Section 55105-1 (55105-1)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:03.299539 · Updated: 2026-03-14T23:08:35.242045