CLOUD BRUSH ON SUNSCREEN SPF 50- zinc oxide cream

Cloud Brush On Sunscreen SPF 50 by

Drug Labeling and Warnings

Cloud Brush On Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by FUTURE 8 LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 25.00%

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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions.

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor. 
• Reapply: 
• after 80 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 the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Coco-Caprylate, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Lens Esculenta (Lentil) Fruit Extract, Polyhydroxystearic Acid, Propanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sodium Stearoyl Glutamate, Squalane, Stearic Acid, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Questions?

(212) 913-0169

Package Labeling:

INGREDIENTS AND APPEARANCE

CLOUD BRUSH ON SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85678-897
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
COCO-CAPRYLATE (UNII: 4828G836N6)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
LENTIL (UNII: 6O38V6B52O)
PROPANEDIOL (UNII: 5965N8W85T)
APPLE (UNII: B423VGH5S9)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85678-897-00	1 in 1 BOX	09/15/2025
1		50 mL in 1 JAR; 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	09/15/2025

Labeler - FUTURE 8 LLC (119503136)

Registrant - Pure Source, LLC (080354456)