ALL NATURAL LIP BALM 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 - ALL NATURAL LIP BALM SPF-30

ACTIVE INGREDIENTS

ZINC OXIDE 8%

PURPOSE

SUNSCREEN

USES

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 PROTECTIONS 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

ARGANIA SPINOSA (ARGAN) KERNEL OIL, BEESWAX (CERA ALBA), BEHENYL BEHENATE, BISABOLOL, BUTYROSPERMUM PARKII (SHEA BUTTER), EUPHORBIA CERIFERA (CANDELILLA) WAX, CAPRYLIC/CAPRIC TRIGLYCERIDES, COCOS NUCIFERA (COCONUT) OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERYL CAPRYLATE, GLYCERYL UNDECYLENATE, HYDROGENATED METHYL ABIETATE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEAIA REBAUDIANA, TOCOPHERYL ACETATE, VEGETABLE OIL.

OTHER INFORMATION

01b LBL_S-S_Lip Balm SPF-30_US

ALL NATURAL LIP BALM  SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARGAN OIL (UNII: 4V59G5UW9X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BEHENYL BEHENATE (UNII: K8NU647RJ0)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
CASTOR OIL (UNII: D5340Y2I9G)  
STEVIA LEAF (UNII: 6TC6NN0876)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71585-103-214.25 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)

Revised: 4/2019
Document Id: 4e6ec930-814c-456a-b6fe-ea692cd486c9
Set id: 39c9c1c3-fde9-42a5-8f76-43af06b6be30
Version: 6
Effective Time: 20190411
 
SALT AND STONE