FDA.reportPublic FDA data

Impact Melanoma SPF 30

Manufacturer
RENU LABORATORIES, LLC
Effective date
2025-03-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:14

Label at a glance#

ProductImpact Melanoma SPF 30
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
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 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating. reapply immediately after towel drying. Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protec...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

IMPACT MELANOMA SPF 30

sunscreen is broad spectrum, water

resistant (80 minutes), free of parabens

and made for all skin types

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Purpose

OTC - PURPOSE SECTION

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% 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 consult physician if irritation or rash develops.
  • Keep out of reach of children.
  • If product is swallowed, get medical attention or contact poison control center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating.
  • reapply immediately after towel drying.
  • Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
  • Limited time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6 months, consult a physician.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sunlight.
  • May stain some fabrics.

RECENT MAJOR CHANGES SECTION

Minor word changes in Administration such as apply liberally rather than apply generously

No Major changes in Uses section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Impact SPF LABELImpact SPF LABEL

LABEL FOR IMPACT MELANOMA SPF

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-598-012025-03-13C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30
76348-598-012025-01-30C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-598-01Impact Melanoma SPF 301000 g in 1 JUGLOTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-598IMPACT MELANOMA SPF 30 (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250316_f953302e-f712-129a-e053-6294a90ab9a8.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-59876348-598-01

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
MALVA SYLVESTRIS FLOWER12X9JI52BSIACT
ASIAN GINSENGCUQ3A77YXIIACT
GLYCERINPDC6A3C0OXIACT
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT
COMFREY LEAFDG4F8T839XIACT
ZINC OXIDESOI2LOH54ZACTIB
SORBITOL506T60A25RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE 3502Y53S6ATLUIACT
CETYL ALCOHOL936JST6JCNIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
ISOCETYL STEARATE3RJ7186O9WIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
STEARIC ACID4ELV7Z65APIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT

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
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
ndc (package): 76348-598-01
ndc (product): 76348-598
ndc11 (package): 76348059801
spl id: 303ba855-5a04-602e-e063-6394a90adcb0
spl set id: f953302e-f712-129a-e053-6294a90ab9a8

Reported adverse events (FAERS/openFDA)#

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