Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3
Route
TOPICAL
Published
Effective Date 2020-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.028 g) Homosalate (0.096 g) Octisalate (0.048 g) Octocrylene
Inactive Ingredients
Aminomethylpropanol Benzyl Alcohol Butylene Glycol Alkyl (c12-15) Benzoate Citric Acid Monohydrate Diethylhexyl Syringylidenemalonate Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Glycerin Hydrogenated Soybean Lecithin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Pentylene Glycol Polysorbate 60 Potassium Sorbate Silicon Dioxide Sodium Benzoate Carboxypolymethylene Sorbitan Isostearate Titanium Dioxide Water Xanthan Gum Linalool, (+/-)- Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-10
Description

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

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 50565-1

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

Section 50566-9

Stop use and ask doctor if rash occurs

Section 50567-7

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

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying
  • 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.
Do Not Use On
  • damaged or broken skin
Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Butylene Glycol, Pentylene Glycol, C12-15 Alkyl Benzoate, Silica, Dimethicone, Hydrogenated Lecithin, Fragrance/Parfum, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Carbomer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Diethylhexyl Syringylidenemalonate, Aminomethyl Propanol, Citric Acid Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool, Titanium Dioxide (CI 77891).

Active Ingredients (w/w)

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Principal Display Panel – 150 Ml Carton Label

RODAN+FIELDS

ESSENTIALS

Face + Body

Sunscreen

Broad

Spectrum

SPF

50

Everyday

Active

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

RODAN + FIELDS

150 mL/5.0 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 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs

Section 50567-7 (50567-7)

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

Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying
  • 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.
Do Not Use On (Do not use on)
  • damaged or broken skin
Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Butylene Glycol, Pentylene Glycol, C12-15 Alkyl Benzoate, Silica, Dimethicone, Hydrogenated Lecithin, Fragrance/Parfum, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Carbomer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Diethylhexyl Syringylidenemalonate, Aminomethyl Propanol, Citric Acid Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool, Titanium Dioxide (CI 77891).

Active Ingredients (w/w)

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Principal Display Panel – 150 Ml Carton Label (Principal Display Panel – 150 mL Carton Label)

RODAN+FIELDS

ESSENTIALS

Face + Body

Sunscreen

Broad

Spectrum

SPF

50

Everyday

Active

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

RODAN + FIELDS

150 mL/5.0 Fl. Oz. U.S.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.492654 · Updated: 2026-03-14T23:01:55.379030