Drug labels

EltaMD UV Lip Balm SPF31

ZINC OXIDE AND OCTINOXATE SUNSCREEN · CP Skin Health, Inc · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
0ec70f0a-cda4-4953-b056-e1e6e9921e5b
ID
4f13545b-ccc0-435e-b2a9-008a90f03050
Effective time
20240125
Version
5
SPL product data elements

EltaMD UV Lip Balm SPF31 zinc oxide and octinoxate sunscreen ZINC OXIDE ZINC CATION OCTINOXATE OCTINOXATE MICROCRYSTALLINE WAX PETROLATUM CASTOR OIL LAURYL LAURATE OLIVE OIL HYDROGENATED CASTOR OIL WHITE WAX CARNAUBA WAX CANDELILLA WAX HYDROGENATED SOYBEAN OIL GLYCERYL STEARATE SE HIGH DENSITY POLYETHYLENE GLYCERYL DIBEHENATE .ALPHA.-TOCOPHEROL ACETATE, DL- ASCORBYL PALMITATE THIOCTIC ACID QUERCETIN CAESALPINIA SPINOSA RESIN GLYCERIN

Warnings

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 ingredient
Active Ingredients Octinoxate 7.5% Sunscreen Zinc Oxide 9.0% Sunscreen
Purpose

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.

Indications and usage

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.

Dosage and administration

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 ingredient

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 KEEP OUT OF REACH OF CHILDREN
Package label principal display panel
Labeling UV Lip Balm UC
Harmonized identifiers (openFDA)
Application number
M020
Brand name
EltaMD UV Lip Balm SPF31
Generic name
ZINC OXIDE AND OCTINOXATE SUNSCREEN
Manufacturer name
CP Skin Health, Inc
Product NDC
72043-2510
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE, OCTINOXATE
SPL ID
4f13545b-ccc0-435e-b2a9-008a90f03050
SPL set ID
0ec70f0a-cda4-4953-b056-e1e6e9921e5b
Package NDC
72043-2510-8
Is original packager
true
UNII
SOI2LOH54Z, 4Y5P7MUD51
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.