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 aging caused by the sun.
Cream
- Manufacturer
- Oxygen Development LLC
- Effective date
- 2022-05-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:30
Label at a glance#
ProductCream
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections
Dosage and administration
Shake before use. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protec...
Storage and handling
Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222
Label contents#
Full prescribing information#
Active Ingredients
Titanium Dioxide 4.55%
Zinc Oxide 3.5%
Purpose
Sunscreen
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.
Warnings
For external use only. Stop use and ask a doctor if rash occurs. Do not use on damage or broken skin.
When using this product
When using this product keep out of eyes. Rinse with water to remove.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control center right away.
Directions
Shake before use. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Other information
Protect the product in this container from excessive heat and direct sunlight.
You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients
Cyclopentasiloxane, Isododecane, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder
Package Label - Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-063-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7973-d83d-e063-dadaa90ab31f | Tarte high - performance naturals BB tinted tratment primer Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-063-01 | Cream | 100 mg in 1 TUBE | LOTION | 100 | 1 | |
| 61354-063-01 | Cream | 1 in 1 CARTON | LOTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cream
- Zinc oxide, Titanium diosxide
- TITANIUM DIOXIDE
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- PEG-10 DIMETHICONE (600 CST)
- ZINC OXIDE
- ISODODECANE
- POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
- HEXYL LAURATE
- POLYGLYCERYL-4 ISOSTEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-063 | 61354-063-01 |
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 |
|---|---|---|---|---|---|---|
| de59c3df-f3f0-2f24-e053-2a95a90acaa0 | de59c3df-f3ef-2f24-e053-2a95a90acaa0 | 2022-05-06 | Warnings | de59c3df-f3f0-2f24-e053-2a95a90acaa0 de59c3df-f3ef-2f24-e053-2a95a90acaa0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.