Storage and handling
Store in a cool place
TITANIUM DIOXIDE - Shantou Woodsleep Biotechnology Co., Ltd.
- Manufacturer
- Shantou Woodsleep Biotechnology Co., Ltd.
- Effective date
- 2026-06-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:35:46
Label at a glance#
ProductBROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
Active ingredientPHENYLBENZIMIDAZOLE SULFONIC ACID, AVOBENZONE, TITANIUM DIOXIDE, OCTOCRYLENE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Titanium Dioxide、Ensulizole/Phenylbenz imidazole Sulfonic Acid、Avobenzone 、Octocrylene
OTC - PURPOSE SECTION
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.
OTC - WHEN USING SECTION
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 increases your 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. — 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
STORAGE AND HANDLING SECTION
Store in a cool place
INACTIVE INGREDIENT SECTION
Water, Alcohol Denat., Glycerin, Cyclopentasiloxane, Titanium Dioxide, Niacinamide, Polyacrylate Crosspolymer-6, Dimethicone, Isododecane, PEG-10 Dimethicone, Triethylhexanoin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Disodium EDTA, Tocopherol, Iron Oxides (CI 77491)
DOSAGE & ADMINISTRATION SECTION
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 increases your 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. — 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.
INDICATIONS & USAGE SECTION
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 increases your 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. — 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
- TITANIUM DIOXIDE
- MEDIUM-CHAIN TRIGLYCERIDES
- PANTHENOL
- CI 77491
- PHENYLBENZIMIDAZOLE SULFONIC ACID
- AVOBENZONE
- AQUA
- GLYCERIN
- CARBOMER
- GLYCERYL STEARATE
- OCTOCRYLENE
- 1,2-HEXANEDIOL
- ARGININE
- CI 77492
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85053-007 | 85053-007-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| PANTHENOL | WV9CM0O67Z | IACT |
| CI 77491 | 1K09F3G675 | IACT |
| PHENYLBENZIMIDAZOLE SULFONIC ACID | 9YQ9DI1W42 | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| AQUA | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER | 0A5MM307FC | IACT |
| GLYCERYL STEARATE | 230OU9XXE4 | IACT |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| 1,2-HEXANEDIOL | TR046Y3K1G | IACT |
| ARGININE | 94ZLA3W45F | IACT |
| CI 77492 | EX438O2MRT | 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 |
|---|---|---|---|---|---|---|
| BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN | TITANIUM DIOXIDE | Shantou Woodsleep Biotechnology Co., Ltd. | 54fc80b7-8f6c-e2be-e063-6394a90a4b59 | 2026-06-24 | Warnings | 85053-007-01 85053-007 85053000701 54fc80b7-8f6d-e2be-e063-6394a90a4b59 54fc80b7-8f6c-e2be-e063-6394a90a4b59 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.