SUNZEE

Manufacturer
Emilia Cosmetics Ltd
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:29:28

Label at a glance#

ProductSUNZEE Broad Spectrum SPF 40 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Storage and handling

Other information protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Titanium Dioxide, 7.1%

Zinc Oxide, 3.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Sunscreen

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

• 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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

•apply liberally 15 minutes before sun exposure

•reapply at least every 2 hours

•use water resistant sunscreen if swimming or sweating

•children under 6 months of age: ask a doctor

• 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-sleeved shirts, pants, hats and sunglassses

STORAGE AND HANDLING SECTION

Other information protect the product in this

container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredients water, caprylic/capric

triglyceride, sesamum indicum (sesame) seed oil,

trimethoxycaprylylsilane, helianthus annuus (sunflower)

seed oil, glycerin, coco-glucoside, coconut alcohol, ricinus

communis (castor) oil, simmondsia chinensis (jojoba) seed

oil, butyrospermum parkii (shea) butter, microcrystalline

cellulose, cellulose gum, arachidyl alcohol, behenyl

alcohol, arachidyl glucoside, phenoxyethanol,

ethylhexylglycerin, xanthan gum, PEG-40 stearate,

fragrance, allantoin, tocopheryl acetate (viatmin E),

panthenol (pro-vitamin B5), lecithin, soy isoflavones,

polysorbate 80, alcohol denat., hippophae rhamnoides

oil, bisabolol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-30043219-300-40, 43219-300-12, 43219-300-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe69fda7-b186-0370-e053-6294a90a0328ffd6941e-ca63-499e-93ab-db327de793ca2023-06-18WarningsExact identifier
spl set id: ffd6941e-ca63-499e-93ab-db327de793ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.