Drug Facts

Active Ingredient

Zinc Oxide 18%

Purpose

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 ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure
Reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
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 a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Other information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Brassica Oleracea Italica (Broccoli) Extract, Butyloctyl Salicylate, Camellia Sinensis (Green Tea Extract), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glyceryl Stearate, Glyceryl Undecylenate, Glyceryl Laurate, Isododecane, Sodium Stearoyl Glutamate, Squalane, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

305-399-7580

Package Labeling:

Label

MIAMI BEACH BUM SAVE FACE SHEER MINERAL SUNSCREEN SPF 50
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82812-447
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	180 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
BROCCOLI (UNII: UOI4FT57BZ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL LAURATE (UNII: Y98611C087)
ISODODECANE (UNII: A8289P68Y2)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82812-447-00	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/18/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/18/2024

Labeler - MIAMI BEACH BUM (116222380)

MIAMI BEACH BUM Save Face Sheer Mineral Sunscreen SPF-50