Indications and 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.
EltaMD UV Lip Balm SPF31
- Manufacturer
- CP Skin Health, Inc | Swiss-American CDMO, LLC
- Effective date
- 2024-01-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:47
Label at a glance#
ProductEltaMD UV Lip Balm SPF31
Active ingredientZINC OXIDE, OCTINOXATE
Label structure8 sections
Dosage and administration
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, e...
Label contents#
Full prescribing information#
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72043-2510-8 | EltaMD UV Lip Balm SPF31 | 8 g in 1 TUBE | LOTION | 8 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72043-2510 | ELTAMD UV LIP BALM SPF31 (ZINC OXIDE AND OCTINOXATE SUNSCREEN) LOTION [CP SKIN HEALTH, INC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240221_0ec70f0a-cda4-4953-b056-e1e6e9921e5b.zip |
Products#
Every source-derived product name is available through these pages.
- EltaMD UV Lip Balm SPF31
- zinc oxide and octinoxate sunscreen
- ZINC OXIDE
- ZINC CATION
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72043-2510 | 72043-2510-8 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EltaMD UV Lip Balm SPF31 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health, Inc | 0ec70f0a-cda4-4953-b056-e1e6e9921e5b | 2024-01-25 | Warnings | 72043-2510-8 72043-2510 72043251008 4f13545b-ccc0-435e-b2a9-008a90f03050 0ec70f0a-cda4-4953-b056-e1e6e9921e5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.