TROPICAL PINEAPPLE JUMBO LIP BALM- oxybenzone, octinoxate, homosalate lipstick
Yoyo Lip Gloss Inc.

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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Active Ingredients
Benzophenone-3: 10%

Ethylhexyl Methoxycinnamate: 10%

Homosalate: 10%

Purpose: Sunscreen

Warnings:

For external use only

USE ONLY AS DIRECTED

NOT A TOY

RECOMMENDED FOR AGES 8 & UP

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

Children under 2 years ask a doctor

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

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.

Uses Helps prevent sunburn

image of tube label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Yoyo Lip Gloss Inc. (828881792)