Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 9acbf663-15e4-4572-a267-56afa58a347b
Route
TOPICAL
Published
Effective Date 2023-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.036 g) Zinc Oxide (0.0234 g)
Inactive Ingredients
3-(triethoxysilyl)propylamine Ammonia Butylene Glycol Butyloctyl Salicylate Alkyl (c12-15) Benzoate Calcium Gluconate Medium-chain Triglycerides Caprylyl Trisiloxane Cynara Scolymus Leaf Dimethicone Dimethicone/peg-10/15 Crosspolymer Dipropylene Glycol Disteardimonium Hectorite Ethylhexylglycerin Gluconolactone Glycerin Isododecane Isostearic Acid Magnesium Sulfate, Unspecified Form Nylon-12 Peg-9 Polydimethylsiloxyethyl Dimethicone Pentylene Glycol Phenethyl Benzoate Phenoxyethanol Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid (2300 Mw) Propanediol Propylene Carbonate Rosmarinic Acid Rutin Silicon Dioxide Sodium Benzoate Sodium Citrate, Unspecified Form Stearic Acid Tocopherol Triethylhexanoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-09

Description

Titanium Dioxide 3.6% Zinc Oxide 2.34%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.6% Zinc Oxide 2.34%

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.
Warnings

For external use only.

Directions
  • Shake well before use.
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating and 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 AM - 2 PM.
    • 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

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Aminopropyl Triethoxysilane, Ammonium Hydroxide, Aqua/Eau/Water, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Disteardimonium Hectorite, Ethylhexylglycerin, Gluconolactone, Glycerin, Isododecane, Isostearic Acid, Magnesium Sulfate, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Nylon-12, PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Rosmarinic Acid, Rutin, Silica, Sodium Benzoate, Sodium Citrate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopherol, Triethylhexanoin.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask 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

SOOTHE

4

Daily Mineral Sunscreen

Broad Spectrum SPF 30

Principal Display Panel 30 Ml Carton Label

RODAN+FIELDS

SOOTHE

Daily Mineral Sunscreen

Broad Spectrum SPF 30

4

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.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Shake well before use.
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating and 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 AM - 2 PM.
    • 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

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Aminopropyl Triethoxysilane, Ammonium Hydroxide, Aqua/Eau/Water, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Disteardimonium Hectorite, Ethylhexylglycerin, Gluconolactone, Glycerin, Isododecane, Isostearic Acid, Magnesium Sulfate, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Nylon-12, PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Rosmarinic Acid, Rutin, Silica, Sodium Benzoate, Sodium Citrate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopherol, Triethylhexanoin.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask Doctor If (Stop use and ask 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

SOOTHE

4

Daily Mineral Sunscreen

Broad Spectrum SPF 30

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

RODAN+FIELDS

SOOTHE

Daily Mineral Sunscreen

Broad Spectrum SPF 30

4

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


Advanced Ingredient Data


Raw Label Data

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