MAKETA SUNSCREEN WITH ALOE VERA SPF 30- octinoxate, octisalate, and oxybenzone lotion

Maketa Sunscreen with Aloe Vera SPF 30 by

Drug Labeling and Warnings

Maketa Sunscreen with Aloe Vera SPF 30 by is a Otc medication manufactured, distributed, or labeled by Makéta™ Sunscreen Lotion with Aloe Vera SPF 30, BMC 1092, Inc. dba Solo Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:		Purpose
Octinoxate	7.5%	Sunscreen
Octisalate	5.0%	Sunscreen
Oxybenzone	6.0%	Sunscreen

Uses

• * Helps prevent sunburn

Warnings

Skin Cancer/ Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• * Apply liberally 15 minutes before sun exposure.
• * Use a water resistant sunscreen if swimming or sweating.
• * Reapply at least every 2 hours.
• * Children under 6 months: Ask a Doctor

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butylparaben, Carbomer, Dimethicone, Ethylparaben, Fragrance, Glyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben, Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid, Water.

SPL UNCLASSIFIED SECTION

Distributed By Makéta, LLC Chicago, Illinois

PRINCIPAL DISPLAY PANEL - 532 ml Bottle Label

SPF 30

ALOE

Makéta™
sunscreen
LOTION

Aloe Vera
Sun Screen Lotion

NET WT. 18 FL. OZ. (532 ml)

Makéta, LLC

INGREDIENTS AND APPEARANCE

MAKETA SUNSCREEN WITH ALOE VERA SPF 30 
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72102-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Allantoin (UNII: 344S277G0Z)
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)
Gulose, L- (UNII: J96E9Q45N7)
Mineral Oil (UNII: T5L8T28FGP)
Hexamethyldisiloxane (UNII: D7M4659BPU)
Aminomethylpropanol (UNII: LU49E6626Q)
Stearic Acid (UNII: 4ELV7Z65AP)
Aloe vera leaf (UNII: ZY81Z83H0X)
Phenoxyethanol (UNII: HIE492ZZ3T)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Cetostearyl alcohol (UNII: 2DMT128M1S)
Polysorbate 60 (UNII: CAL22UVI4M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72102-047-06	177 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018
2	NDC: 72102-047-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - Makéta™ Sunscreen Lotion with Aloe Vera SPF 30 (081031516)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc. dba Solo Laboratories, Inc		078831987	MANUFACTURE(72102-047) , LABEL(72102-047)