ALL NATURAL LIP BALM SPF-30- zinc oxide lotion

ALL NATURAL LIP BALM by

Drug Labeling and Warnings

ALL NATURAL LIP BALM by is a Otc medication manufactured, distributed, or labeled by SALT AND STONE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 8%

PURPOSE

SUNSCREEN

USES

• 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

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

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL NATURAL LIP BALM  SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-103-21	4.25 g in 1 TUBE; Type 0: Not a Combination Product	08/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2017

Labeler - SALT AND STONE (080683697)