SALT AND STONE MINERAL SUNSCREEN SPF 50- zinc oxide lotion

SALT AND STONE MINERAL SUNSCREEN SPF 50 by

Drug Labeling and Warnings

SALT AND STONE MINERAL SUNSCREEN SPF 50 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

Non-Nano Zinc Oxide 22.8%

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

if 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 the risk, regularly
use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including:
Limit time in the sun, especially from 10am - 2pm.
Wear long-sleeve 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/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Caprilic/capric triglyceride, Dimethicone, Octyl Palmitate, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Cera Alba (Beeswax), Glycerol, Polyethylene, Rosa Canina (Rosehip) Seed Oil, Persea Gratissima (Avocado) Oil, Hyaluronic Acid, Ethylhexylglycerin, Phenoxyethanol, Glyceryl Oleate, Xanthan gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

SALT AND STONE MINERAL SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	228 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYALURONIC ACID (UNII: S270N0TRQY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL OLEATE (UNII: 4PC054V79P)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size	88mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-130-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2019

Labeler - Salt and Stone LLC (080683697)