PREMIUM SUNSCREEN SPF-30- 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 PREMIUM SUNSCREEN SPF-30

ACTIVE INGREDIENTS

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

IF RASH OCCURS, DISCONTINUE USE AND CONSULT A HEALTH CARE PRACTITIONER.

WHEN USING THIS PRODUCT: KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

For use on children less than 6 months of age, consult a health care practitioner. Apply liberally/generously (and evenly) 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. 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 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.

INACTIVE INGREDIENTS

*Aloe Barbadensis Juice, *Cera Alba (Beeswax), Cetearyl Alcohol, Citric Acid, *Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, *Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Phenoxyethanol, *Simmondsia Chinesnsis (Jojoba) Oil, Sodium Citrate, Sodium Stearoyl Lactylate, Stearic Acid, *Theobroma Cacao (Cocoa) Butter, *Tocopherol (Vitamin E), *Vanilla, *Vitellaria Paradox (Shea) Butter, Xanthan Gum

*Certified Organic

OTHER INFORMATION

QUESTIONS OR COMMENTS?

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01b LBL_S&S_Premium Sunscreen SPF-30_US

PREMIUM SUNSCREEN  SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
JOJOBA OIL (UNII: 724GKU717M)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCOA BUTTER (UNII: 512OYT1CRR)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VANILLA (UNII: Q74T35078H)  
SHEA BUTTER (UNII: K49155WL9Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-105-2188 mL in 1 TUBE; Type 0: Not a Combination Product08/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/29/2017
Labeler - SALT AND STONE (080683697)

Revised: 7/2019
Document Id: d341c489-cabe-41a5-a568-7635b89ecd12
Set id: a3732451-ac84-4c56-8e01-3c92c3e857b3
Version: 4
Effective Time: 20190728
 
SALT AND STONE