IMPACT MELANOMA SPF 30- zinc oxide lotion

Impact Melanoma SPF 30 by

Drug Labeling and Warnings

Impact Melanoma SPF 30 by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

IMPACT MELANOMA SPF 30

sunscreen is broad spectrum, water

resistant (80 minutes), free of parabens

and made for all skin types

Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

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.

WARNINGS

• 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.

Keep out of reach of children.

DIRECTIONS

• 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

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

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

Questions or Comments?

Visit www.BrightGuard.com or call (310) 589-4116

PRINCIPAL DISPLAY PANEL

LABEL FOR IMPACT MELANOMA SPF

INGREDIENTS AND APPEARANCE

IMPACT MELANOMA SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-598
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.5 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	10 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12.5 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GLYCERIN (UNII: PDC6A3C0OX)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
COMFREY LEAF (UNII: DG4F8T839X)
SORBITOL (UNII: 506T60A25R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-598-01	1000 g in 1 JUG; Type 0: Not a Combination Product	04/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/17/2023

Labeler - RENU LABORATORIES, LLC (119451815)

Registrant - RENU LABORATORIES, LLC (119451815)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, LLC		119451815	manufacture(76348-598)