Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
EltaMD UV SPF35
- Manufacturer
- CP Skin Health Group, Inc | Swiss-American CDMO, LLC
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:10
Label at a glance#
ProductEltaMD UV SPF35
Active ingredientZINC OXIDE, OCTINOXATE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least 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 in the sun, especially fro...
Contacts and useful links#
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. Rinse with water to remove. Stop use and ask a physician if rash occurs. 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
Indications & Uses:
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Indications & Uses:
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Keep out of reach of children
Keep out of reach of children
Directions
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least 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 in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
Other information:
Protect this product from excessive heat and direct sun.
Inactive ingredients
water, petrolatum, isopropyl palmitate, ethylhexyl stearate, dimethicone, phenoxyethanol, glyceryl stearate, PEG-100 stearate, oleth-3 phosphate, cetearyl alcohol, cetearyl glucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, polyether-1, ethylhexylglycerin, PEG-7 trimethylolpropane coconut ether, citric acid, tocopheryl acetate, sodium hyaluronate, triethoxycaprylylsilane
Questions?
Call toll free 1-800-633-8872
Labeling
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  colgate.red/0001-2291-226g | UV Lotion UC 02291A.jpg |
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 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72043-6808-2 | EltaMD UV SPF35 | 2 g in 1 PACKET | LOTION | 2 | 4 | |
| 72043-6808-3 | EltaMD UV SPF35 | 85 g in 1 TUBE | LOTION | 85 | 4 | |
| 72043-6808-8 | EltaMD UV SPF35 | 226 g in 1 TUBE | LOTION | 226 | 4 |
Products#
Every source-derived product name is available through these pages.
- EltaMD UV SPF35
- octinoxate, zinc oxide sunscreen
- ZINC OXIDE
- ZINC CATION
- OCTINOXATE
- WATER
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- PETROLATUM
- DIMETHICONE
- ISOPROPYL PALMITATE
- OCTYL STEARATE
- OLETH-3 PHOSPHATE
- CETOSTEARYL ALCOHOL
- CETEARYL GLUCOSIDE
- GLYCERYL STEARATE/PEG-100 STEARATE
- CITRIC ACID MONOHYDRATE
- .ALPHA.-TOCOPHEROL ACETATE
- HYALURONIC ACID
- POLYISOBUTYLENE (1000 MW)
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72043-6808 | 72043-6808-8, 72043-6808-2, 72043-6808-3 |
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 SPF35 | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 3029d6ed-a60b-4789-a567-d09b12d76bf4 | 2025-12-19 | Warnings | 72043-6808-8 72043-6808-3 72043-6808-2 72043-6808 72043680808 72043680803 72043680802 b988dc70-eb19-4c6d-935e-74439188a438 3029d6ed-a60b-4789-a567-d09b12d76bf4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.