MINERAL SUNSCREEN - WATER RESISTANT SPF-50- zinc oxide lotion 
SALT AND STONE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SALT & STONE MINERAL SUNSCREEN SPF-50 - WATER RESISTANT

ACTIVE INGREDIENTS

ZINC OXIDE 22.8%

PURPOSE

SUNSCREEN

USE

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

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

USA SPF Lotion_50_1

MINERAL SUNSCREEN - WATER RESISTANT  SPF-50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-109-2188 mL in 1 TUBE; Type 0: Not a Combination Product07/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/28/2019
Labeler - SALT AND STONE (080683697)

Revised: 7/2019
Document Id: 9020ca2c-0a1d-46f6-aca6-c15aa07548a5
Set id: 6a63e108-65f7-49b5-8ed1-5016d446ec2e
Version: 1
Effective Time: 20190728
 
SALT AND STONE