ALLAY SKIN SOLUTIONS PROTECT NOURISH MINERAL SUNSCREEN SPF 42- titanium dioxide, zinc oxide cream

Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 by

Drug Labeling and Warnings

Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 by is a Otc medication manufactured, distributed, or labeled by ALLAY SKIN SOLUTIONS LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 2.50 %

Zinc Oxide 14.00 %

Purpose

Sunscreen

Uses:

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• 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

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children

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

If pregnant or breast-feeding,

ask a health professional before use

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• 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 the risk, regularly use a sunscreen with broad spectrum SPF 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

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

1,2-Hexanediol, Butyloctyl Salicylate, C18-21 Alkane, Camelina Sativa Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Cholecalciferol, Coco-Caprylate/Caprate, Cyclopentasiloxane, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Root Extract , Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isododecane, Isostearyl Palmitate, Linum Usitatissimum Seed Oil, Niacinamide, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Polysorbate 20, Propanediol, Ricinus Communis (Castor) Seed Oil, Silybum Marianum Extract, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Thermus Thermophillus Ferment, Trimethylsiloxysilicate,Water (Aqua), Xanthan Gum

 Questions?

(385) 204-5618

Package Labeling:

INGREDIENTS AND APPEARANCE

ALLAY SKIN SOLUTIONS PROTECT NOURISH MINERAL SUNSCREEN SPF 42 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87419-978
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C18-C21 ALKANE (UNII: 33822S0M40)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
NIACINAMIDE (UNII: 25X51I8RD4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
CASTOR OIL (UNII: D5340Y2I9G)
MILK THISTLE (UNII: U946SH95EE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87419-978-00	1 in 1 BOX	01/07/2026
1		50 mL in 1 TUBE; 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	01/07/2026

Labeler - ALLAY SKIN SOLUTIONS LLC (119553107)

Registrant - Pure Source, LLC (080354456)