WALGREENS SPF 50 TINTED MINERAL FLUID- titanium dioxide lotion

Walgreens SPF 50 Tinted Mineral Fluid by

Drug Labeling and Warnings

Walgreens SPF 50 Tinted Mineral Fluid by is a Otc medication manufactured, distributed, or labeled by Walgreens, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 11%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

WARNINGS

For external use only.

do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation developss and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

For sunscreen use: shake well before use, apply liberally 15 minutes before sun exposure and as needed, reapply:

after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

C12-15 alkyl bonzoate, water, isododecane, diemthicone, styrene/acrylates copolymer, undecane, triethylhexanoin, butyloctyl salicylate, nylon-12, isohexadecane, caprylyl methicone, phenethyl benzoate, aluminum stearate, dimethicone/PEG-10/15 crosspolymer, dicaprylyl carbonate, tridecane, disteardimonium hectorite, dicaprylyl ether, pentyle glycol, silica, propylene carbonate, phenoxyethanol, ethylhexylglycerin, stearic acid, PEG-8 laurate, PEG-9 polydimethylsiloxyethyl dimethicone, magnesium sulfate, benzoic acid, disodium stearoyl glutamate, tocopherol, diethylhexyl syringylidenemalonate, caprylic/capric triglyceride, iron oxides (CI 77492, CI 77499, CI 77491), triethoxycaprylysilane, maltodextrin, cassia alata leaf extract, polyhydroxystearic acid, alumina

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS SPF 50 TINTED MINERAL FLUID 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1812
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM SULFATE (UNII: DE08037SAB)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PEG-8 LAURATE (UNII: 762O8IWA10)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CI 77499 (UNII: XM0M87F357)
UNDECANE (UNII: JV0QT00NUE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
ALUMINA (UNII: LMI26O6933)
ISODODECANE (UNII: A8289P68Y2)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE 200 (UNII: RGS4T2AS00)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CI 77491 (UNII: 1K09F3G675)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
TRIDECANE (UNII: A3LZF0L939)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CI 77492 (UNII: EX438O2MRT)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1812-01	1 in 1 CARTON	11/03/2025
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/03/2025

Labeler - Walgreens (008965063)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(0363-1812)