Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin againg caused by the sun.
One and Done
- Manufacturer
- Thirteen Lune Inc.
- Effective date
- 2022-05-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:44
Label at a glance#
ProductOne and Done
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this rick, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measure including: Limit time in the sun, especially from...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
ZINC OXIDE 1%
TITANIUM DIOXIDE 2%
Purpose
SUNSCREEN
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 doctor if rash occurs.
Keep out of reach of children.
If product is swallowed get medical help or contact a Poison Control Center right away.
Keep outer carton for complete labeling information.
Uses
Helps prevent sunburn.
If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin againg caused by the sun.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this rick, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measure including:
- Limit time in the sun, especially from 10 a.m. - 2p.m.
- Wear long sleeve shirts, pants, hats and sunglasses.
Children under 6 months: Ask a doctor
Questions
(888) 305-2032
Inactive Ingredients
Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Niacinamide, Cetyl Alcohol, Glyceryl Stearate, Squalane, PEG-75 Stearate, Phenoxyethanol, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl, Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/Silicate Crosspolymer, Allantoin, Caprylyl Glycol, Hippophae Rhamnoides Seed Oil, Prunus, Domestica Seed Oil, Mauritia Flexuosa Fruit Oil, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Ethylhexylglycerin, Hexylene Glycol, Sodium Hyaluronate, Trilaureth-4 Phosphate, Butylene Glycol, Disodium EDTA, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Plankton Extract, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Kigelia Africana Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Ascorbate, Tocopherol.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
Principal Display Panel
50ML RELEVANT ONE + DONE 50ML
15ML RELEVANT ONE + DONE SPF
4ML RELEVANT ONE + DONE SACHET (SAMPLE)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82735-200-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-605f-d83d-e063-dadaa90ab31f | dfc98ed9-5eb8-477a-e053-2995a90a8316 |
| 82735-200-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-605f-d83d-e063-dadaa90ab31f | dfc98ed9-5eb8-477a-e053-2995a90a8316 |
| 82735-200-03 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-605f-d83d-e063-dadaa90ab31f | dfc98ed9-5eb8-477a-e053-2995a90a8316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82735-200-01 | One and Done | 50 mL in 1 TUBE | CREAM | 50 | 2 | |
| 82735-200-02 | One and Done | 15 mL in 1 TUBE | CREAM | 15 | 2 | |
| 82735-200-03 | One and Done | 4 mL in 1 PACKET | CREAM | 4 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- One and Done
- SPF 40
- ZINC OXIDE
- TITANIUM DIOXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82735-200 | 82735-200-01, 82735-200-02, 82735-200-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| dfdd038b-04ae-2431-e053-2995a90a77c5 | dfc98ed9-5eb8-477a-e053-2995a90a8316 | 2022-05-25 | Warnings | dfdd038b-04ae-2431-e053-2995a90a77c5 dfc98ed9-5eb8-477a-e053-2995a90a8316 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.