COOLA ZINC OXIDE BODYLOTION SPF 50 FRAGRANCE-FREE- zinc oxide lotion

COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free by

Drug Labeling and Warnings

COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Goodier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actice Ingredient

Zinc Oxide 12.61%

Purpose

Zinc Oxide 12.61%...............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

• Shake well.
• Apply liberally 15 minutes before sun exposure
• 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 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
• May stain fabrics

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl Salicylate, Glycerin (ORGANIC), Polyglyceryl-6 Stearate, Oryza Sativa (Rice) Bran Oil (ORGANIC), Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer, Microcrystalline Cellulose, Sesamum Indicum (Sesame) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Saccharomyces Ferment Filtrate (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, 1,2-Hexanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diheptyl Succinate, Ethyl Ferulate, Glyceryl Stearates, Hydroxyacetophenone, Polyglyceryl-6 Behenate, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, Tropolone, Water (Aqua), Xanthan Gum

Questions or comments?

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

COOLA

SPF 50

Zinc Oxide

Sunscreen Lotion

Fragrance Free

Sheer Finish

Hydrates & Nourishes

Plus Plant Protection

Broad Spectrum SPF 50

Water Reistant (80 Minutes)

Mineral

1.4 FL OZ/41 ML

INGREDIENTS AND APPEARANCE

COOLA ZINC OXIDE BODYLOTION SPF 50 FRAGRANCE-FREE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.61 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
ETHYL FERULATE (UNII: 5B8915UELW)
TROPOLONE (UNII: 7L6DL16P1T)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
CRYPTOMERIA JAPONICA LEAF SACCHAROMYCES CEREVISIAE FERMENT FILTRATE (UNII: ZF3R3PTA9C)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
SESAMUM INDICUM (SESAME) SEED OIL (UNII: QX10HYY4QV)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-108-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2026
2	NDC: 79753-108-02	41 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2026

Labeler - COOLA LLC (956990290)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics		007317209	manufacture(79753-108)