COOLA SUNBLUR PRIMER SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

COOLA SunBlur Primer SPF 50 by

Drug Labeling and Warnings

COOLA SunBlur Primer SPF 50 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bell International Laboratories, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 7.0%, Octisalate 5.0%, Octocrylene 9.0%

Purpose

Avobenzone 3.0%, Homosalate 7.0%, Octisalate 5.0%, Octocrylene 9.0% ............ 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:
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

Other information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Isododecane, Dimethicone Crosspolymer, Butyloctyl Salicylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Dimethicone, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Argania Spinosa Kernel Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Tapioca Starch, Dimethicone/Polyglycerin-3 Crosspolymer, Glycerin, Silica, Jasminum Sambac (Jasmine) Leaf Cell Extract, Oryza Sativa (Rice) Bran Extract, Water, Propanediol, Butylene Glycol, Polymethylsilsesquioxane, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Mangostin, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Fragrance (Natural)

Questions or comments?

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

COOLA

SPF 50

SunBlur
Primer
Sunscreen

Primes + Protects
Invisible Matte Finish

Featuring
BlueScreen

Digital De-Stress Technology

Broad Spectrum SPF 50

1 FL OZ / 30 mL

COOLA

SPF 50

SunBlur
Primer
Sunscreen

Primes + Protects
Invisible Matte Finish

Featuring
BlueScreen

Broad Spectrum SPF 50

1 FL OZ / 30 mL

INGREDIENTS AND APPEARANCE

COOLA SUNBLUR PRIMER SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
MANGOSTIN (UNII: U6RIV93RU1)
ISODODECANE (UNII: A8289P68Y2)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
SILICA (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
SCHINUS MOLLE WHOLE (UNII: 7NY65X282C)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
THEOBROMA CACAO (COCOA) SEED POWDER (UNII: D9108TZ9KG)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ROSEMARY (UNII: IJ67X351P9)
TAPIOCA STARCH (UNII: 24SC3U704I)
JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-106-01	1 in 1 CARTON	02/01/2026
1		30 mL in 1 BOTTLE, PUMP; 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	02/01/2026

Labeler - COOLA LLC (956990290)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(79753-106)