5298 sunscreen

Manufacturer
Innovation Specialties
Effective date
2017-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:54:57

Label at a glance#

Product5298 sunscreen
Active ingredientOCTOCRYLENE, TITANIUM DIOXIDE, OCTISALATE
Label structure11 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 15minutes before sun exposure •reapply:   •after 40 minutes of swimming or sweating   •immediately after towel drying   •at least every 2 hours • Sun Protection Measure . 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 of 15 higher and other sun protection measures including:   •limit time ...

Storage and handling

•protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 9%

Titanium dioxide 7%

Octisalate 5%

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 on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If products is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•apply liberally 15minutes before sun exposure
•reapply:
  •after 40 minutes of swimming or sweating
  •immediately after towel drying
  •at least every 2 hours
•Sun Protection Measure. 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 of 15 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: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, CETETH-25, Glyceryl Stearate, Glycerin, Dmdm Hydantoin, Methyl Paraben, Propylparaben, Fragrance

Other information

STORAGE AND HANDLING SECTION

•protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

NDC (76138-215-02) DIN 02448890
Made in China for Innovation line.
Los Angeles CA 90066
Questions or Comments?
Call:1-855-755-5346

SPL UNCLASSIFIED SECTION

Sunscreen Lotion SPF30

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76138-21576138-215-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
dbe13314-fb20-498f-89f1-df681054c09407e8b370-0233-419a-9fea-e38ee73baabb2022-05-13WarningsExact identifier
spl set id: 07e8b370-0233-419a-9fea-e38ee73baabb

Reported adverse events (FAERS/openFDA)#

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