PREMIUM SUNSCREEN FACE SPF-50- zinc oxide, octinoxate 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

ACTIVE INGREDIENTS

ZINC OXIDE 15%

OCTINOXATE 3%

PURPOSE

SUNSCREEN

USES

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DESCREASES THE RISK OF SKIN CANCER AND EARLY 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 OCCURSS.

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 THIS RISK, REGULARLY USE A SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

  • LIMIT TIME IN THE SUN, FROM 10 A.M. - 2 P.M.
  • WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR

INACTIVE INGREDIENTS

* HELIANTHUS ANNUUS (SUNFLOWER) OIL, * COCOS NUCIFERA (COCONUT) OIL, * CERA ALBA (BEESWAX), * BUTYROSPERMUM PARKII (SHEA) BUTTER, SILICA, * COPERNICIA PRUNIFERA (CARNAUBA) WAX, * THEOBROMA CACAO (COCOA) BUTTER, MICA, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, VITAMIN E, IRON OXIDE, TITANIUM DIOXIDE

* ORGANIC

OTHER INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

QUESTIONS OR COMMENTS?

CALL TOLL FREE 1 888 952 4250

BigFace stick wrap label_90PCT_revised

PREMIUM SUNSCREEN FACE  SPF-50
zinc oxide, octinoxate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
COCOA BUTTER (UNII: 512OYT1CRR)  
MICA (UNII: V8A1AW0880)  
JOJOBA OIL (UNII: 724GKU717M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-101-1130 g in 1 TUBE; Type 0: Not a Combination Product08/29/201712/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/29/201712/02/2018
Labeler - SALT AND STONE (080683697)
Establishment
NameAddressID/FEIBusiness Operations
JOSHUA TREE PRODUCTS LLC016171726manufacture(71585-101)

Revised: 12/2018
 
SALT AND STONE