COOLA ANTI-AGING HAND CREAM SUNSCREEN- avobenzone, octocrylene, octisalate cream

Coola Anti-Aging Hand Cream Sunscreen by

Drug Labeling and Warnings

Coola Anti-Aging Hand Cream Sunscreen by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Goodier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone, Octocrylene, Octisalate

Purpose

Avobenzone 2.5%, Octocrylene 7.5%, Octisalate 4.0%..................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 doctor if skin 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:
• At least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC); Cetearyl Alcohol, Oryza Sativa (Rice) Bran Oil (ORGANIC); Caprylic/Capric Triglycderide (ORGANIC); Glycerin (ORGANIC); Stearic Acid, Butyloctyl Salicylate, Mangifera Indica (Mango) Seed Butter (ORGANIC); Sesamum Indicum (Sesame) Seed Oil (ORGANIC); Glyceryl Stearate; Jojoba Esters; Arnica Montana FLower Extract (ORGANIC); Water (Aqua); 1,2-Hexanediol; Glyceryl Stearates; Xanthan Gum; Caprylyl Glycol; Helianthus Annuus (Sunflower) Seed Wax; Sodium Stearoyl Glutamate; Hyroxyacetophenone; Rubus Idaeus (Raspberry) Seed Oil; Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC); Tetrasodium Glutamate Diacetate; Polyglycerin-3; Tropolone; Butylene Glycol; Fragrance (Natural)

Other information

• Protect this product from excessive heat and direct sun
• May stain fabrics

Questions or comments?

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

COOLA

SPF 30

Anti-Aging

Hand Cream

Sunscreen

Featuring

Organic Arnica Extract +

Mango Seed Butter

Broad Spectrum SPF 30

2.0 FL OZ / 60 mL

INGREDIENTS AND APPEARANCE

COOLA ANTI-AGING HAND CREAM SUNSCREEN 
avobenzone, octocrylene, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROPOLONE (UNII: 7L6DL16P1T)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SESAMUM INDICUM (SESAME) SEED OIL (UNII: QX10HYY4QV)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MANGIFERA INDICA (MANGO) SEED BUTTER (UNII: 4OXD9M35X2)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-105-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/12/2025

Labeler - COOLA LLC (956990290)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics		007317209	manufacture(79753-105)