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.
Cream
- Manufacturer
- OXYGEN DEVELOPMENT, LLC
- Effective date
- 2023-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:56
Label at a glance#
ProductCream
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections
Dosage and administration
Shake before use. Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen of 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 our risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protect...
Storage and handling
Shake before use. Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen of 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 our risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protect...
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 skin aging caused by the sun.
Warnings
For external use only
OTC - STOP USE SECTION
Stop use and ask doctor if rash occurs.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 of 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 our risk of skin cancer and early skin aging. To decrease this 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.- 2p.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, Mica, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides.
Primary Package (Inner)
15 ML 61354-051-36
Secondary Package (Outer)
15 ml 61354-051-36
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-051-36 | 2025-01-30 | C162847 | 48780-1 | f386c649-d162-0266-e053-dadaa90a7c1a | BB TINTED TREATMENT PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN. MEDIUM 12-HOUR PRIMER |
| 61354-051-36 | 2023-02-10 | C162847 | 48780-1 | f386c649-d162-0266-e053-dadaa90a7c1a | BB TINTED TREATMENT PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN. MEDIUM 12-HOUR PRIMER |
| 61354-051-36 | 2023-01-30 | C162847 | 48780-1 | f386c649-d162-0266-e053-dadaa90a7c1a | BB TINTED TREATMENT PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN. MEDIUM 12-HOUR PRIMER |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-051-36 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-36 | Cream | 15 mg in 1 TUBE | LOTION | 15 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cream
- Titanium Dioxide, Zinc Oxide
- POLYMETHYLSILSESQUIOXANE (11 MICRONS)
- HEXYL LAURATE
- ISODODECANE
- MICA
- POLYGLYCERYL-4 ISOSTEARATE
- PEG-10 DIMETHICONE (600 CST)
- STEARIC ACID
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- CYCLOMETHICONE 5
- ZINC OXIDE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-051 | 61354-051-36 |
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 |
|---|---|---|---|---|---|---|
| f45cf528-2bfc-ff03-e053-2a95a90ad530 | bc3f580a-63e8-c8e9-e053-2995a90aa4f6 | 2023-02-10 | Warnings | f45cf528-2bfc-ff03-e053-2a95a90ad530 bc3f580a-63e8-c8e9-e053-2995a90aa4f6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.