CLASSIC BODY PLUMERIA SPF 30 BROAD SPECTRUM- sunscreen lotion
Bell International Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coola SPF 30 Classic Body Sunscreen Lotion Plumeria

Active Ingredients

Avobenzone 1.9%

Octinoxate 2.2%

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 eyews. 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:

after 40 minutes 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 wtih a borad specturm SPF of 15 or highter and other sun protection measures including:

limit time in the sun, especially from 10am-2pm
wear long-sleeve shirts, pants, hats and sunglasses
Children under 6 monts: Ask a doctor

Inactive Ingredients

Argania Spinosa (ORGANIC) Kernel Oil, Butyrospermum Parkii (ORGANIC Shea Butter), Caprylhydroamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Citric Acid, Citrus Aruantium Dulcis (ORGANIC Orange) Fruit Water, Cucumis Sativus (ORGANIC Cucumber) Fruit Extract, Dicaprylyl Carbonate, Fragrance, Glycerin (ORGANIC), Oenothera Biennis (ORGNAIC Evening Primrose) Oil, Olea Europaea (ROGANIC Olive) Fruit Oil, Plankton Extract, Rosa Canina (ORGANIC) Fruit Extract, Shellac, Sodium Hydroxide, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum.

Other Information

Protect this product from excessive heat and direct sun

secondary box

box

tube

CLASSIC BODY PLUMERIA SPF 30 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
OLIVE OIL (UNII: 6UYK2W1W1E)
WATER (UNII: 059QF0KO0R)
ORANGE (UNII: 5EVU04N5QU)
XANTHAN GUM (UNII: TTV12P4NEE)
SHELLAC (UNII: 46N107B71O)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
CUCUMBER (UNII: YY7C30VXJT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SHEA BUTTER (UNII: K49155WL9Y)
ARGAN OIL (UNII: 4V59G5UW9X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-111-10	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2015	01/01/2021

Labeler - Bell International Laboratories (967781555)

Revised: 1/2021

Document Id: b8de0202-1c37-fe46-e053-2995a90a5e15

Set id: 56e50169-9415-0800-e054-00144ff8d46c

Version: 2

Effective Time: 20210114

Bell International Laboratories