UNSCENTED CLASSIC FACE 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 Classic Face SPF 30 Moisturizing Unscented

Active Ingredients

Avobenzone 2.0%, Octinoxate 2.1%

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 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:

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 a broad spectrum SPF or 15 or higher and other sun protectin measures including:

limit time in the sun, especially from 10am-2pm
wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: ask a doctor

Inactive Ingredients

Caprylohydroxamic Acid

Caprylyl Glycol

Carthamus Tinctorius (Safflower) Oleosomes

Citrus Aurantium Dulcis (Orange) Fruit Water

Dicaprylyl Carbonate

Euterpe Oleracea (Acai) Fruit Oil

Fragaria Vesca (Strawberry) Fruit Extract

Glycerin

Helianthus Annuus (Sunflower) Seed Extract

Hydrogenated Polydecene

Linum Usitatissimum (Linseed) Seed Oil

Oenothera Biennis (Evening Primrose) Oil

Plankton Extract

Propanediol

Sodium Polyacryloyldimethyl Taurate

Sodium Stearoyl Glutamate

Trideceth-10

Trisodium Ethylenediamine Disuccinate

Water

Xanthan Gum

Other Information

protect this product from excessive heat and direct sun

tube artwork

tube

display box

UNSCENTED CLASSIC FACE SPF 30 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-114
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ORANGE (UNII: 5EVU04N5QU)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED (UNII: R9N3379M4Z)
ALPINE STRAWBERRY (UNII: CG6IX3GCMU)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ACAI OIL (UNII: Z0W6766A2W)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
LINSEED OIL (UNII: 84XB4DV00W)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-10 (UNII: G624N6MSBA)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-114-11	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2014	01/01/2021

Labeler - Bell International Laboratories (967781555)

Revised: 1/2021

Document Id: b8de074d-1919-1de7-e053-2a95a90aa370

Set id: 55f2e487-0e3b-15b1-e054-00144ff8d46c

Version: 2

Effective Time: 20210114

Bell International Laboratories