FDA.reportPublic FDA data

in2itiv SPF30 Sunscreen

Manufacturer
Redi-2-PaQ Home Products
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:12

Label at a glance#

Productin2itiv SPF30 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage and administration

• Apply liberally 15 minutes before sun exposure • at least every 2 hours • Use a water resistant sunscreen if swimming or sweating. Reapply Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad-Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially fr...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6%

Zinc Oxide (non-nano) 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

WARNINGS SECTION

  • DO NOT EAT CONTENTS 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 if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed seek medical attention 24 HOUR EMERGENCY INFORMATION Call 1-800-535-5053

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • at least every 2 hours • Use a water resistant sunscreen if swimming or sweating.

Reapply

Sun Protection Measures.

  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad-Spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Avocado Oil, Beeswax, Cetyl Esters, Coconut Oil, Ethyl Linoleate, Fragrance, Lecithin, Monolaurin, Sunflower Oil, Stearyl Dimethicone, Tri Ethyl Citrate, Water

Questions?

OTC - QUESTIONS SECTION

Visit www.penta5USA.com or call toll free 1-800-511-5609

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72697-000372697-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
AVOCADO OIL6VNO72PFC1IACT
CETYL ESTERS WAXD072FFP9GUIACT
COCONUT OILQ9L0O73W7LIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
GLYCERYL LAURATEY98611C087IACT
SUNFLOWER OIL3W1JG795YIIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
WATER059QF0KO0RIACT
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
298aa116-845f-8f18-e063-6294a90ad6488d818d54-c59a-4e33-97df-4731e06f05ab2024-12-18WarningsExact identifier
spl set id: 8d818d54-c59a-4e33-97df-4731e06f05ab

Reported adverse events (FAERS/openFDA)#

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