FDA.reportPublic FDA data

VERTRA Premium Suncare SPF 30 Spray

Manufacturer
Eai-Jr286, Inc.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:00

Label at a glance#

ProductVERTRA Premium Suncare SPF 30
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  • 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: Sun Protection Measures. • Limi...

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 

• 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: Sun Protection Measures.

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

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71014-029-00VERTRA Premium Suncare SPF 30177 mL in 1 CANSPRAY1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71014-029VERTRA PREMIUM SUNCARE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) SPRAY [EAI-JR286, INC.]3Current NDC, Legacy NDC, 1 package rows20231106_720ca725-24ca-4b59-b640-afa983238692.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71014-02971014-029-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYL PALMITATE2865993309IACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
COCONUT OILQ9L0O73W7LIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CARROTL56Z1JK48BIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
WATERMELON231473QB6RIACT
NORI477TV3P5UXIACT
MANGOI629I3NR86IACT
XANTHAN GUMTTV12P4NEEIACT
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
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
ndc (package): 71014-029-00
ndc (product): 71014-029
ndc11 (package): 71014002900
spl id: 0974b923-cfe4-7dcc-e063-6294a90aeb1b
spl set id: 720ca725-24ca-4b59-b640-afa983238692

Reported adverse events (FAERS/openFDA)#

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