FDA.reportPublic FDA data

UV PROTECT FACE SPF 50

Manufacturer
Naos USA, Inc.
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:19:44

Label at a glance#

ProductUV PROTECT FACE SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Help prevent sunburn.

Dosage and administration

Adults 18 years and older: Apply liberally and evenly 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 incl...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Titanium Dioxide 8.82%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older:

  • Apply liberally and evenly 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.
  • Children under 6 months of age: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Keep the product between 15-30ºC (59-86ºF)
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Coco-caprylate/caprate, Caprylic/Capric Triglyceride, Methyl Methacrylate Crosspolymer, Dicaprylyl Ether, Dicaprylyl Carbonate, Silica Dimethyl Silylate, Oryza Sativa (Rice) Bran Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Fragrance (Parfum), Stearyl Glycyrrhetinate, Tocopherol, Farnesol.

Questions?

OTC - QUESTIONS SECTION

Call to 1 877 443 3762

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label2Outer Label2Inner Label2Inner Label2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14324-011UV PROTECT FACE SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NAOS USA, INC.]6Legacy NDC20231130_64431eff-e7a8-2a22-e053-2991aa0aecf9.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14324-01114324-011-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL ETHER77JZM5516ZIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
WHITE RICEA195V20H7AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
TOCOPHEROLR0ZB2556P8IACT
FARNESOLEB41QIU6JLIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
0b41a486-6e39-a1a7-e063-6294a90ace2164431eff-e7a8-2a22-e053-2991aa0aecf92023-11-28WarningsExact identifier
spl id: 0b41a486-6e39-a1a7-e063-6294a90ace21
spl set id: 64431eff-e7a8-2a22-e053-2991aa0aecf9