CLOUD BRUSH ON SUNSCREEN CLEAR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene gel

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Avobenzone 3.00 %
Homosalate 7.00 %
Octisalate 5.00 %
Octocrylene 10.00 %

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.

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

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Dimethicone/Bis- Isobutyl PPG-20 Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Isododecane, Tocopherol, Tridecyl Salicylate

Questions?

(212) 913-0169

Package Labeling:

INGREDIENTS AND APPEARANCE

CLOUD BRUSH ON SUNSCREEN CLEAR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85678-997
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CUCUMBER (UNII: YY7C30VXJT)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85678-997-00	1 in 1 BOX	12/04/2024
1		20 mL in 1 BOTTLE, WITH APPLICATOR; 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	12/04/2024

Labeler - FUTURE 8 LLC (119503136)

Registrant - Pure Source, LLC (080354456)