SALT AND STONE LIGHTWEIGHT SHEER MINERAL SUNSCREEN SPF30- zinc oxide lotion

Salt and Stone Lightweight Sheer Mineral Sunscreen SPF30 by

Drug Labeling and Warnings

Salt and Stone Lightweight Sheer Mineral Sunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by SALT & STONE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 15.7%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other skin 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 occurs.

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Sun protection Measures.

• Limit time in the sun, especially from 10am - pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Children under 6 months: Ask a doctor

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Chondrus Crispus Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexyl Olivate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Jojoba Esters, Laminaria Digitata Extract, Macrocystis Pyrifera (Keip) Extract, Magnesium Sulfate, Niacinamide, Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Diisostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Squalane, Tocopherol, Trihydroxystearin, Water, Xanthan Gum.

Questions or Comments?

info@saltandstone.com

Package Labeling:

INGREDIENTS AND APPEARANCE

SALT AND STONE LIGHTWEIGHT SHEER MINERAL SUNSCREEN SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	157 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
ISODODECANE (UNII: A8289P68Y2)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-144-00	1 in 1 BOX	09/01/2023
1		60 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	09/01/2023

Labeler - SALT & STONE, INC. (080683697)