SPF 30 MINERAL SUNSCREEN- zinc oxide lotion

SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

SPF 30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Salt and Stone LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Zinc Oxide (Non-Nano) 22.7%

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

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 

ir rash occurs.

Keep out of reach of children.

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

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
• 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 10am-2 2pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Coco-caprylate, Polyglyceryl-3 polyricinoleate, Isostearic acid, Purified water, medium chain triglycerides, Octyl palmitate, Dimethicone, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Glycerol, Beeswax, Polyethylene, Gluconolactone, Sodium benzoate, Calcium gluconate, Glyceryl Monooleate, Avocado oil, Fragrace, Rosa canina (rose hip) oil, Hyaluronic acid, Xanthan gum.
Organic Ingredient

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF 30 MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	227 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE (UNII: 4828G836N6)
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYALURONIC ACID (UNII: S270N0TRQY)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-135-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	09/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/28/2019

Labeler - Salt and Stone LLC (080683697)