Label: ALL NATURAL LIP BALM SPF-30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71585-103-21 - Packager: SALT AND STONE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL NATURAL LIP BALM SPF-30
zinc oxide lotionProduct 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)
