MAXIMUM REPAIR SPF 50 BROAD SPECTRUM- spf 50 cream

MAXIMUM REPAIR SPF 50 by

Drug Labeling and Warnings

MAXIMUM REPAIR SPF 50 by is a Otc medication manufactured, distributed, or labeled by EVI LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

• Avobenzone 3%
• Homosalate 10%
• Octinoxate 6%
• Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.
• Higher SPF gives more sunburn protection

Directions

• Apply liberally 15 minutes before sun exposure.
• At least, every two hours.
• Immediately after swimming, sweating, or towel drying.

Administration

For external use

Warnings

• 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's

Keep out of children. If the product is swallowed, get medical attention or contact the poison control center immediately.

Inactive Ingredients

Water purified, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Glycerin, Cetearyl Alcohol, Zemea-Propylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Beeswax, Jojoba Oil, Organic (Simmondsia Chinensis Seed Oil), Dicaprylyl Carbonate, Isopropyl Myristate, Stearyl Alcohol, Acrylate Copolymer, Dimethicone Fluido, Polysorbate-20, Vitamin E (Tocopheryl Acetate), Phenoxyethanol SA, Carbomer, Butyloctyl Salicylate, Hydrolyzed Collagen, Hydrolyzed Jojoba Protein, Methyl Methacrylate Crosspolymer, Vitamin B3 (Niacinamide), Sodium EDTA, Sodium Ascorbyl Phosphate (Vitamin C), Xanthan Gum, Fragrance and Ehylhexylglyrecin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM REPAIR SPF 50  BROAD SPECTRUM
spf 50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84178-008
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.8 g  in 48 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 g  in 48 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.44 g  in 48 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.88 g  in 48 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)	0.96 g  in 48 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	0.72 g  in 48 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.96 g  in 48 g
GLYCERIN (UNII: PDC6A3C0OX)	1.44 g  in 48 g
ALOE (UNII: V5VD430YW9)	2.4 g  in 48 g
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)	0.096 g  in 48 g
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)	0.48 g  in 48 g
CUCUMBER JUICE (UNII: 61845009SP)	0.96 g  in 48 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.144 g  in 48 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.096 g  in 48 g
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)	0.96 g  in 48 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	0.72 g  in 48 g
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)	0.01 g  in 48 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.44 g  in 48 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1.44 g  in 48 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.24 g  in 48 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.144 g  in 48 g
PANTHENOL (UNII: WV9CM0O67Z)	0.12 g  in 48 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.48 g  in 48 g
NIACINAMIDE (UNII: 25X51I8RD4)	0.24 g  in 48 g
COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)	0.24 g  in 48 g
WATER (UNII: 059QF0KO0R)	20.39 g  in 48 g
DIMETHICONE 20 (UNII: H8YMB5QY0D)	0.48 g  in 48 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.24 g  in 48 g
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)	0.24 g  in 48 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.096 g  in 48 g
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)	1.032 g  in 48 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.576 g  in 48 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84178-008-01	1 in 1 BOX	10/09/2024
1		48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/09/2024

Labeler - EVI LABS (123617598)

Establishment
Name	Address	ID/FEI	Business Operations
EVI LABS		123617598	manufacture(84178-008)