LYPSYL VANILLA PLUM INTENSE PROTECTION- lip balm lipstick

LypSyl Vanilla Plum by

Drug Labeling and Warnings

LypSyl Vanilla Plum by is a Otc medication manufactured, distributed, or labeled by Lornamead, CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octyl Methoxycinnamate 5.5%...................................Sunscreen

Octylcrylene 2.0%....................................................Sunscreen

Oxybenzone 3.5%....................................................Sunscreen

Avobenzone 3.0%.....................................................Sunscreen

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea Butter), Ceresin, Euterpe Oleracea (Acai) Fruit Extract, Flavor, Hydrogenated Coconut Oil, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Tocopheryl Acetate

Directions

• apply liberally 15 minutes before sun exposure
• after 40 minutes of swimming or sweating
• at least every 2 hours
• children under 6 months: ask a doctor

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 Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including

• limit time in the sun, especially from 10a.m. -2 p.m.
• wear long-sleeved shirts, pants hats and sunglasses

Other Information

Protect this product from excessive heat and direct sun.

Use

Helps prevent sunburn

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Questions or Comments

• call 877-995-5405
• www.lypsylhome.com
• or email customerservice @lornameadna.com

PRINCIPAL DISPLAY PANEL

MM1.jpg

MM2.jpg

INGREDIENTS AND APPEARANCE

LYPSYL VANILLA PLUM  INTENSE PROTECTION
lip balm lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62721-8127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.0 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
YELLOW WAX (UNII: 2ZA36H0S2V)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
ACAI (UNII: 46AM2VJ0AW)

Product Characteristics
Color		Score
Shape		Size
Flavor	PLUM (Vanilla Plum)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62721-8127-8	2.83 in 1 BLISTER PACK
1	NDC: 62721-8127-6	2.83 g in 1 CANISTER

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

Labeler - Lornamead (126440440)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(62721-8127) , pack(62721-8127)