SUNSCREEN SPF-50 TINTED- zinc oxide stick 
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 FACE STICK SPF-50 TINTED

ACTIVE INGREDIENTS

ZINC OXIDE 22.5%

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

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. REAPPL AFTER 80 MINUTES OF SWIMMING OR SWEATING OR IMMEDIATELY AFTER TOWEL DRYING. REAPPLY 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 THIS RISK, REGULARLY USE A SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

INACTIVE INGREDIENTS

* TYROSPERMUM PARKII (SHEA) BUTTER, * BEESWAX (CIRE D'ABIELLE), * COCOS NUCIFERA (COCONUT) OIL, SILICA, * COPERNICIA PRUNIFERA (CARNAUBA) WAX,* HELIANTHUS ANNUUS (SUNFLOWER) OIL, IRON OXIDE, MICA, SILICA, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * THEOBROMA CACAO (COCOA) BUTTER, VITAMIN E.

* CERTIFIED ORGANIC

OTHER INFORMATION

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01b LBL_Face Stick SPF-50 Tinted_US_front

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SUNSCREEN  SPF-50 TINTED
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
JOJOBA OIL (UNII: 724GKU717M)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-106-1115 g 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
Filltech USA, LLC926433855manufacture(71585-106)

Revised: 5/2019
Document Id: 8a6ba2a7-715d-43ba-b483-40916cdda133
Set id: 7afc8a56-7ca0-4147-a19e-b7aa2b4b9377
Version: 1
Effective Time: 20190524
 
SALT AND STONE