CLASSIC MOISTURIZING BODY SPF 30 BROAD SPECTRUM- sunscreen unscented lotion

Classic Moisturizing Body by

Drug Labeling and Warnings

Classic Moisturizing Body by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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:

• after 40 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: 10am-2pm
• wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive Ingredients

Argania Spinosa Kernel Oil

Butyrospermum Parkii (Shea Butter)

Caprylhydroxamic Acid

Caprylyl Glycol

Carthamus Tinctorius (Safflower) Oleosomes

Citric Acid

Citrus Aurantium Dulcis (Orange) Fruit Water

Cucumis Sativus (Cucumber) Fruit Extract

Dicaprylyl Carbonate

Glycerin

Oenothera Biennis (Evening Primrose) Oil

Olea Europaea (Olive) Fruit Oil

Plankton Extract

Rosa Canina Fruit Extract

Shellac

Sodium Hydroxide

Trisodium Ethylenediamine Disuccinate

Water

Xanthan Gum

Other Information

protect this product from excessive heat and direct sun

5 oz box label

INGREDIENTS AND APPEARANCE

CLASSIC MOISTURIZING BODY  SPF 30 BROAD SPECTRUM
sunscreen unscented lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-112-10	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2015

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

Labeler - Bell International Laboratories (967781555)