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

Purpose

Sunscreen

Description

Titanium Dioxide 3.6% Zinc Oxide 2.34%


Medication Information

Warnings

For external use only.

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

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.
Other Information

Protect this product from excessive heat and direct sun.

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.

Description

Titanium Dioxide 3.6% Zinc Oxide 2.34%

Questions?

1-888-995-5656

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

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

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

Warnings

For external use only.

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

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.
Other Information

Protect this product from excessive heat and direct sun.

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.

Questions?

1-888-995-5656

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

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

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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