PREMIUM SUNSCREEN SPF-30- zinc oxide, octinoxate 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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MINERAL BASED SALT & STONE PREMIUM SUNSCREEN SPF-30

ACTIVE INGREDIENTS

ZINC OXIDE 10%

OCTINOXATE 7%

PURPOSE

SUNSCREEN

USES

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

REAPPLY:

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 SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

INACTIVE INGREDIENTS

* ALOE BARBADENSIS JUICE, * COCOS NUCIFERA (COCONUT) OIL, * HELIANTHUS ANNUUS (SUNFLOWER) OIL, GLYCERYL STEARATE, * THEOBROMA CACAO (COCOA) BUTTER, * VITELLARIA PARADOX (SHEA) BUTTER, STEARIC ACID, CETEARYL ALCOHOL, SODIUM STEARYL LACTATE, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * CERA ALBA (BEESWAX), * VANILLA, PHENOXYETHANOL, XANTHAN GUM, * TOCOPHEROL (VITAMIN E), SODIUM CITRATE, HYDROXYETHYLCELLULOSE, CITRIC ACID

* 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, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
JOJOBA OIL (UNII: 724GKU717M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
VANILLA (UNII: Q74T35078H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-102-2188 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)
Establishment
NameAddressID/FEIBusiness Operations
JOSHUA TREE PRODUCTS LLC016171726manufacture(71585-102)

Revised: 4/2019
Document Id: 58ef100b-ef4e-4388-90b2-5139dd4ae285
Set id: f4f5db0a-1d8b-48fd-bdc2-a19308cdfe92
Version: 3
Effective Time: 20190411
 
SALT AND STONE