CLASSIC BODY PLUMERIA SPF 30 BROAD SPECTRUM- sunscreen lotion

Classic Body Plumeria by

Drug Labeling and Warnings

Classic Body Plumeria 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 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

tube

INGREDIENTS AND APPEARANCE

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

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
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
OLIVE OIL (UNII: 6UYK2W1W1E)
WATER (UNII: 059QF0KO0R)
ORANGE (UNII: 5EVU04N5QU)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
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)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-111-10	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)