FDA.reportPublic FDA data

VERTRA Premium Suncare SPF 50 Lotion

Manufacturer
EAI-JR286, Inc
Effective date
2020-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:37:57

Label at a glance#

ProductVERTRA Premium Suncare SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and 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

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 15 or higher and other sun protection measures including: • Limit ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.0%
Zinc Oxide 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

• keep out of eyes

• Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deonized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ethylhexyl Palmitate, Zemea (Corn) Propanediol, Glyceryl Stearate, Tridecyl Salicylate, Helianthus Annuus (Sunflower) Oil, Decyl Glucoside, Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Glycerin, Stearic Acid, Glyceryl Caprylate, Glyceryl Undecylenate, Parfum (Fragrance), Algae Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Mangifera Indica (Mango) Butter, Tocopheryl Acetate (Vitamin E), Fucus Vesiculosus (Seaweed) Extract, Hippophae Rhamnoides (Sea Buckthorn) Oil, Xanthan Gum, Hydroxyethylcellulose, Cetearyl Alcohol.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71014-01771014-017-00, 71014-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYL PALMITATE2865993309IACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
WATERMELON231473QB6RIACT
CARROTL56Z1JK48BIACT
MANGOI629I3NR86IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
NORI477TV3P5UXIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
07574155-0fb1-d615-e063-6394a90acaaf20f3deda-33ae-4cd3-adfe-fb2973264e4e2023-10-10WarningsExact identifier
spl set id: 20f3deda-33ae-4cd3-adfe-fb2973264e4e

Reported adverse events (FAERS/openFDA)#

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