SEYE
3cce91b1-311b-4c95-e063-6294a90a2d7a
HUMAN OTC DRUG LABEL
Aug 20, 2025
Guangzhou Seye Biomedical Technology Co., Ltd.
DUNS: 714724607
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Oxide and Titanium Dioxide Cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (23)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
The Texture Is Fresh, Not Sticky, Light And Moist.
Effectively blocks ultraviolet rays, prevents sunburn, photoaging, and pigmentation, while also having auxiliary functions such as moisturizing and skin conditioning to help maintain the skin's hydrated state during sun protection. Suitable for daily or outdoor protection needs.
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
For external use only.
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 - STOP USE SECTION
Stop use and ask a doctor if
- Rash occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
Pregnancy or breast feeding section
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(s)
- Zinc Oxide 20%
- Titanium Dioxide 10%
OTC - PURPOSE SECTION
Purpose(s)
- Sunscreen
- Sunscreen
DOSAGE & ADMINISTRATION SECTION
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 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:
1. limit time in the sun, especially from 10 a.m. - 2 p.m.
2. Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
OTHER SAFETY INFORMATION
Other information
- Protect this product from excessive heat and direct sun
INACTIVE INGREDIENT SECTION
Inactive ingredients
AQUA, ZINC OXIDE, TITANIUM DIOXIDE, GLYCERIN, ETHYLHEXYL PALMITATE, SQUALANE, ISOHEXADECANE, C14-22 ALCOHOLS, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROXYACETOPHENONE, C12-20 ALKYL GLUCOSIDE, CARBOMER, ARGININE, XANTHAN GUM, BUTYLENE GLYCOL, ALPHA-TOCOPHEROL ACETATE, ALOE BARBADENSIS LEAF JUICE, CENTELLA ASIATICA LEAF, OLEA EUROPAEA (OLIVE) FRUIT OIL, PAEONIA LACTIFLORA ROOT, CERAMIDE NP, CYCLODEXTRIN
OTC - QUESTIONS SECTION
Questions or comments?
934-935-7135 / Yiqinzhi726@gmail.com