MACKENZIES SPF 40 OCEAN SAFE SUNSCREEN- zinc oxide cream

Mackenzies SPF 40 Ocean Safe Sunscreen by

Drug Labeling and Warnings

Mackenzies SPF 40 Ocean Safe Sunscreen by is a Otc medication manufactured, distributed, or labeled by Naturally Uncommon LLC, Stream2Sea LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

PURPOSE

Sunscreen.

INDICATIONS & USAGE

Helps prevent sunscreen.

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 ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
• For children under 6 months of age; ask a doctor.

INACTIVE INGREDIENT

Alaria Esculenta (Wakame Seaweed) Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Cera Alba (Beeswax), Cetearyl Alcohol, Cetyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Esters, Mixed Tocopherols (Vitamin E), Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalene (Plant Based)

*Certified Organic Ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MACKENZIES SPF 40 OCEAN SAFE SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80325-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ALMOND OIL (UNII: 66YXD4DKO9)
SQUALENE (UNII: 7QWM220FJH)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HOLY BASIL LEAF (UNII: SCJ765569P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80325-040-02	80 g in 1 JAR; Type 0: Not a Combination Product	07/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/17/2024

Labeler - Naturally Uncommon LLC (044473410)

Registrant - Stream2Sea LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea LLC		052920828	manufacture(80325-040)