Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 19.6%

Purpose

Sunscreen

Uses

• 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

on damaged or broken skin Do not use

keep out of eyes. Rinse with water to remove. When using this product

if rash occurs. Stop use and ask a doctor

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: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • . 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 10am - 2pm. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Sun protection Measures

Children under 6 months: Ask a doctor

Other Information

• Protect this product from excess heat and direct sun.

Inactive Ingredients

Water, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea Butter), Capryloyl Glycerin/Sebacic Acid Copolymer, Lavandula Angustifolia (Lavender) Oil, Theobroma Cacao (Cocoa) Seed Butter, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil*, Salvia Officinalis (Sage) Oil, Glycerin*, Caprylhydroxamic Acid, Camellia Sinensis (Green Tea) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*, Withania Somnifera Root Extract.*, Tocopherol, Bisabolol, Cetyl Alcohol, Sodium Gluconate, Citric Acid, Microcrystalline Cellulose, Cellulose Gum, Caprylyl Glycol, Cetearyl Alcohol, Coco-Glucoside, Sodium Stearoyl Glutamate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid. *Organic Ingredient

Package Label

SALT AND STONE NATURAL MINERAL SUNSCREEN SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71585-136
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	196 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
COCOA BUTTER (UNII: 512OYT1CRR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SAGE OIL (UNII: U27K0H1H2O)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71585-136-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/01/2019

Labeler - Salt and Stone LLC (080683697)

Salt & Stone Natural Mineral Sunscreen Lotion SPF 30, 3 fl.Oz.(88 mL)