ZINC OXIDE

Manufacturer
J. A. Cosmetics U.S. INC | Hangzhou Facecare Cosmetics Co., Ltd.
Effective date
2020-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:01:07

Label at a glance#

ProductELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Light Medium
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Zinc Oxide: 13.8%

OTC - PURPOSE SECTION

Purpose:

Sunscreen

INDICATIONS & USAGE SECTION

Uses:

Help prevent sunburn

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

Warning:

For external use only

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 - ASK DOCTOR SECTION

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 immediately

DOSAGE & ADMINISTRATION SECTION

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

  • Limit time in the sun, especially from 10 am to 2 pm
  • Wear long sleeved shirts, pants, hats, and sunglasses.
  • Children under six months of age: ask a doctor

Other Information:

Protect this product in the container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredient:

Cyclopentasiloxane, Water, Dimethicone, Silica, Isododecane, PEG-10 Dimethicone, Acrylates/Dithicone Copolymer, PEG-9 Dimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Quaternium-18, Bentonite, Dimethicone/PEG-10/15 Crosspolymer, Propylene Carbonate, Triethoxycaprylsilane, Talc, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Pentaerythrityl Tetraisosterate, Paraffinum Liquidum (Mineral Oil), Disteardimonium Hectorite, Palmitoyl Tripeptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (Va), Tocopheryl Acetate (Ve), Ascorbyl Palmitate (Vc), Lycium Barbarum Fruit Extract

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-76176354-761-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
b6c48b50-785e-b424-e053-2995a90a35bab62f5b85-79d9-49bf-8ab3-cb5171300dc32020-12-18WarningsExact identifier
spl id: b6c48b50-785e-b424-e053-2995a90a35ba
spl set id: b62f5b85-79d9-49bf-8ab3-cb5171300dc3

Reported adverse events (FAERS/openFDA)#

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