MINERAL SUNSCREEN - WATER RESISTANT SPF-50- zinc oxide lotion

MINERAL SUNSCREEN - WATER RESISTANT by

Drug Labeling and Warnings

MINERAL SUNSCREEN - WATER RESISTANT by is a Otc medication manufactured, distributed, or labeled by SALT AND STONE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 22.8%

PURPOSE

SUNSCREEN

USE

• 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

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

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.

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN - WATER RESISTANT  SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ROSA CANINA SEED (UNII: 4503R1M9UT)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYALURONIC ACID (UNII: S270N0TRQY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-109-21	88 mL in 1 TUBE; Type 0: Not a Combination Product	07/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/28/2019

Labeler - SALT AND STONE (080683697)