ELTAMD UV LIP BALM SPF31- zinc oxide and octinoxate sunscreen lotion 
CP Skin Health, Inc

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EltaMD UV Lip Balm SPF31

Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Octinoxate 7.5% Sunscreen

Zinc Oxide 9.0% Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Uses

Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at lest 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 sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time int he sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

Petrolatum, Ricinus Communis (Castor) Seed Oil, Cetearyl Alcohol, Lauryl Laurate, Purified Water, Flavor, Polyethylene, Hydrogenated Castor Oil, Olea Europaea (Olive) Fruit Oil, Cera Alba, Glycerin, Copernicia Cerifera (Carnauba) Wax, Glyceryl Behenate, Microcrystalline Wax, Quercetin, Thiotic Acid, Ascorbyl Palmitate, Tocopheryl Acetate, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Soybean Oil, Hydrolyzed Caesalpinia Spinosa Gum, Glyceryl Stearate, Caesalpinia Spinosa Gum

KEEP OUT OF REACH OF CHILDREN 

KEEP OUT OF REACH OF CHILDREN

Labeling

UV Lip Balm UC

ELTAMD UV LIP BALM SPF31 
zinc oxide and octinoxate sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2510
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
CASTOR OIL (UNII: D5340Y2I9G)  
LAURYL LAURATE (UNII: GPW77G0937)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
WHITE WAX (UNII: 7G1J5DA97F)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
QUERCETIN (UNII: 9IKM0I5T1E)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2510-88 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/10/2018
Labeler - CP Skin Health, Inc (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2510)

Revised: 1/2024
Document Id: 4f13545b-ccc0-435e-b2a9-008a90f03050
Set id: 0ec70f0a-cda4-4953-b056-e1e6e9921e5b
Version: 5
Effective Time: 20240125
 
CP Skin Health, Inc