SOOTHE DAILY MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

SOOTHE Daily Mineral Sunscreen by

Drug Labeling and Warnings

SOOTHE Daily Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

Purpose

Sunscreen

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.

Do not use on

• damaged or broken skin.

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.

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

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.

Principal Display Panel - 30 mL Tube Label

RODAN+FIELDS

SOOTHE

4

Daily Mineral Sunscreen

Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

SOOTHE DAILY MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.036 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0234 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552)
AMMONIA (UNII: 5138Q19F1X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
NYLON-12 (UNII: 446U8J075B)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ROSMARINIC ACID (UNII: MQE6XG29YI)
RUTIN (UNII: 5G06TVY3R7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2440-1	1 in 1 CARTON	03/09/2021
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 14222-2440-2	1 in 1 CARTON	06/01/2021
2		7 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 14222-2440-3	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/09/2021

Labeler - Rodan & Fields (051659584)