TROPICAL PINEAPPLE JUMBO LIP BALM- oxybenzone, octinoxate, homosalate lipstick

TROPICAL PINEAPPLE JUMBO LIP BALM by

Drug Labeling and Warnings

TROPICAL PINEAPPLE JUMBO LIP BALM by is a Otc medication manufactured, distributed, or labeled by Yoyo Lip Gloss Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Benzophenone-3: 10%

Ethylhexyl Methoxycinnamate: 10%

Homosalate: 10%

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

USE ONLY AS DIRECTED

NOT A TOY

RECOMMENDED FOR AGES 8 & UP

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts.

ASK DOCTOR

Children under 2 years ask a doctor

DOSAGE & ADMINISTRATION

Directions:
Apply as needed. Apply liberally before sun exposure and as needed.

INACTIVE INGREDIENT

Inactive Ingredients

INGREDIENTS/INGREDIENT: Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Ceresin, Beeswax, Microcrystalline Wax, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea Butter), Stevioside, Flavor, Silica Dimethyl Silylate, Diisostearyl Malate, Bis-diglycery, Polyacyladipate-2, Tocopheryl Acetate, MAY CONTAIN/PEUT CONTENIR: Titanium Dioxide, FD&C Blue No.1, D&C Yellow No.10, D&C Red No.28, Iron Oxides, Mica.

INDICATIONS & USAGE

Uses Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TROPICAL PINEAPPLE JUMBO LIP BALM 
oxybenzone, octinoxate, homosalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70611-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FERROUS OXIDE (UNII: G7036X8B5H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PODOPHYLLUM RESIN (UNII: 16902YVY2B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SHEA BUTTER (UNII: K49155WL9Y)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
CERESIN (UNII: Q1LS2UJO3A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70611-001-01	4.2 g in 1 TUBE; Type 0: Not a Combination Product	04/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2016

Labeler - Yoyo Lip Gloss Inc. (828881792)