SPL v4
SPL
SPL Set ID dc230e1e-bfb8-4d7c-bad5-bff77d78220e
Route
TOPICAL
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.028 g) Homosalate (0.093 g) Octocrylene (0.061 g) Octisalate (0.0467 g)
Inactive Ingredients
Adenosine Aminomethylpropanol Benzyl Alcohol Butylene Glycol Alkyl (c12-15) Benzoate Calcium Gluconate Carboxypolymethylene Citral Citric Acid Monohydrate Cynara Scolymus Leaf Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Glycyrrhizinate Dipotassium Gluconolactone Glycerin Hydrogenated Soybean Lecithin Limonene, (+)- Linalool, (+/-)- Phenoxyethanol Propanediol Rosmarinic Acid Rutin Sesame Seed Silicon Dioxide Sodium Benzoate Soybean Oil Titanium Dioxide Tocopherol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-09 Until 2027-10-30
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn.
  • When 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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Directions
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if 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-2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.
Questions?

1-888-995-5656

Do Not Use On
  • damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 2.8%,

Homosalate 9.3%,

Octisalate 4.67%,

Octocrylene 6.1%

Inactive Ingredients

Adenosine, Aminomethyl Propanol, Aqua/Eau/Water, Benzyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Citral, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/Vinyl Dime­thicone Crosspolymer, Dipotassium Glycyrrhizate, Fragrance/Parfum, Glucono­lactone, Glycerin, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Limonene, Linalool, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Phenoxyethanol, Propanediol, Rosmarinic Acid, Rutin, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Benzoate, Sodium Carbomer, Titanium Dioxide (Cl 77891), Tocopherol, Xanthan Gum.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Principal Display Panel 30 Ml Tube Label

RODAN+FIELDS

REVERSE

Brightening Defense Fluid Lotion

Broad Spectrum SPF 50

3AM

Principal Display Panel 30 Ml Carton Label

RODAN+FIELDS

REVERSE

Brightening Defense

Fluid Lotion

Broad Spectrum SPF 50

3AM

30 mL/1. Fl. Oz. U.S.

Structured Label Content

Uses
  • Helps prevent sunburn.
  • When 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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if 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-2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.
Questions?

1-888-995-5656

Do Not Use On (Do not use on)
  • damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 2.8%,

Homosalate 9.3%,

Octisalate 4.67%,

Octocrylene 6.1%

Inactive Ingredients

Adenosine, Aminomethyl Propanol, Aqua/Eau/Water, Benzyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Citral, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/Vinyl Dime­thicone Crosspolymer, Dipotassium Glycyrrhizate, Fragrance/Parfum, Glucono­lactone, Glycerin, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Limonene, Linalool, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Phenoxyethanol, Propanediol, Rosmarinic Acid, Rutin, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Benzoate, Sodium Carbomer, Titanium Dioxide (Cl 77891), Tocopherol, Xanthan Gum.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Principal Display Panel 30 Ml Tube Label (Principal Display Panel - 30 mL Tube Label)

RODAN+FIELDS

REVERSE

Brightening Defense Fluid Lotion

Broad Spectrum SPF 50

3AM

Principal Display Panel 30 Ml Carton Label (Principal Display Panel - 30 mL Carton Label)

RODAN+FIELDS

REVERSE

Brightening Defense

Fluid Lotion

Broad Spectrum SPF 50

3AM

30 mL/1. Fl. Oz. U.S.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:47.577363 · Updated: 2026-03-14T23:11:35.907821