drug facts

drug facts
SPL v1
SPL
SPL Set ID afa2d42e-b54d-4843-b313-0c44fe5c5d52
Route
topical
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (5.2 g) zinc oxide (5.15 g)
Inactive Ingredients
aluminum oxide aminomethylpropanol ascorbyl glucoside benzyl alcohol levomenol butyloctyl salicylate shea butter medium-chain triglycerides citric acid monohydrate ethylhexyl methoxycrylene ethylhexylglycerin glycerin soy protein hydrogenated soybean lecithin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) isohexadecane niacinamide panthenol pentylene glycol phenoxyethanol polyhydroxystearic acid (2300 mw) polysorbate 60 potassium sorbate sodium benzoate hyaluronate sodium sorbitan isostearate stearic acid superoxide dismutase (saccharomyces cerevisiae) .alpha.-tocopherol acetate triethoxycaprylylsilane tromethamine water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-21
Purpose

Sunscreen

Description

Titanium Dioxide 5.20% Zinc Oxide 5.15%

Medication Information

Warnings

For external use only.

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.
Purpose

Sunscreen

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.
Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alumina, Aminomethyl Propanol, Ascorbyl Glucoside, Benzyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Citric Acid, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Protein, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Niacinamide, Panthenol, Pentylene Glycol, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Potassium Sorbate, Sodium Benzoate, Sodium Dextran Sulfate, Sodium Hyaluronate, Sorbitan Isostearate, Stearic Acid, Superoxide Dismutase, Tocopheryl Acetate, Triethoxycaprylylsilane, Tromethamine, Water/Aqua/Eau, Xanthan Gum

Description

Titanium Dioxide 5.20% Zinc Oxide 5.15%

Questions?

1-888-995-5656

Do Not Use On
  • damaged or broken skin.
Active Ingredients

Titanium Dioxide 5.20%

Zinc Oxide 5.15%

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.

Principal Display Panel 30 Ml Tube Label

RODAN+FIELDS

REVERSE

Brightening Defense Lotion

Broad Spectrum SPF 50 Mineral Sunscreen

3AM

Principal Display Panel 30 Ml Carton Label

RODAN+FIELDS

REVERSE

BRIGHTENING

DEFENSE LOTION

Broad Spectrum SPF 50

Mineral Sunscreen

Daytime Radiance Protector

30 mL/

1. Fl. Oz. U.S.

Structured Label Content

Warnings

For external use only.

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.
Purpose

Sunscreen

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.
Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alumina, Aminomethyl Propanol, Ascorbyl Glucoside, Benzyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Citric Acid, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Protein, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Niacinamide, Panthenol, Pentylene Glycol, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Potassium Sorbate, Sodium Benzoate, Sodium Dextran Sulfate, Sodium Hyaluronate, Sorbitan Isostearate, Stearic Acid, Superoxide Dismutase, Tocopheryl Acetate, Triethoxycaprylylsilane, Tromethamine, Water/Aqua/Eau, Xanthan Gum

Questions?

1-888-995-5656

Do Not Use On (Do not use on)
  • damaged or broken skin.
Active Ingredients

Titanium Dioxide 5.20%

Zinc Oxide 5.15%

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

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

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

RODAN+FIELDS

REVERSE

Brightening Defense Lotion

Broad Spectrum SPF 50 Mineral Sunscreen

3AM

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

RODAN+FIELDS

REVERSE

BRIGHTENING

DEFENSE LOTION

Broad Spectrum SPF 50

Mineral Sunscreen

Daytime Radiance Protector

30 mL/

1. Fl. Oz. U.S.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.773744 · Updated: 2026-03-14T23:09:34.496634