BEACH CLUB MINERAL SUNSCREEN- zinc oxide, octinoxate, oxybenzone, and octisalate lotion

Beach Club Mineral Sunscreen by

Drug Labeling and Warnings

Beach Club Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by R & R Lotion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients			Purpose
Zinc Oxide	6.73%		Sunscreen
Octinoxate	5.75%		Sunscreen
Benzophenone-3	4.50%		Sunscreen
Octisalate	3.83%		Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & 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 a 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 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 10am-2pm
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

DI Water, Ethylhexyl Stearate/Ethylhexyl Palmitate/Diethylhexy Adipate, Propylene Glycol, Glyceryl Stearate (and) PEG-100 Stearate, Cetearyl Alcohol (and) Cetearth-20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Oleth 3 Phosphate, Vitamin E

Other Information

• protect this product from excessive heat and direct sun

Questions or Samples?

1-888-860-7424

SPL UNCLASSIFIED SECTION

Manufactured by:
R&R Lotion
15547 N. 77th Street
Scottsdale, AZ 85260

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

SPF 36

BEACH CLUB
MINERAL SUNSCREEN

Broad Spectrum

32oz. (946ml) ℮

INGREDIENTS AND APPEARANCE

BEACH CLUB MINERAL SUNSCREEN 
zinc oxide, octinoxate, oxybenzone, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	67.3 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	57.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	38.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Ethylhexyl Palmitate (UNII: 2865993309)
Diethylhexyl Adipate (UNII: MBY1SL921L)
Propylene Glycol (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Xanthan Gum (UNII: TTV12P4NEE)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-109-13	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/09/2025
2	NDC: 59555-109-10	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/09/2025

Labeler - R & R Lotion, Inc (062979000)