FDA.reportPublic FDA data

TROPICAL PINEAPPLE JUMBO LIP BALM

Manufacturer
Yoyo Lip Gloss Inc.
Effective date
2016-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:38

Label at a glance#

ProductTROPICAL PINEAPPLE JUMBO LIP BALM
Active ingredientOXYBENZONE, OCTINOXATE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Benzophenone-3: 10%

Ethylhexyl Methoxycinnamate: 10%

Homosalate: 10%

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS SECTION

Warnings:

For external use only

USE ONLY AS DIRECTED

NOT A TOY

RECOMMENDED FOR AGES 8 & UP

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

Children under 2 years ask a doctor

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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 SECTION

Uses Helps prevent sunburn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of tube labelimage of tube label

image of tube labelimage of tube label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70611-001-012020-01-31C16284748780-19d75b9d0-a4b0-f424-e053-dadaa90a57ce2fd24cc7-5007-1117-e054-00144ff88e88

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70611-001TROPICAL PINEAPPLE JUMBO LIP BALM (OXYBENZONE, OCTINOXATE, HOMOSALATE) LIPSTICK [YOYO LIP GLOSS INC.]1Legacy NDC20160411_2fd24cc7-5007-1117-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70611-00170611-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 28767IP0Y5NHIACT
FERROUS OXIDEG7036X8B5HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PODOPHYLLUM RESIN16902YVY2BIACT
HOMOSALATEV06SV4M95SACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
ETHYLHEXYL PALMITATE2865993309IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
YELLOW WAX2ZA36H0S2VIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SHEA BUTTERK49155WL9YIACT
STEVIOSIDE0YON5MXJ9PIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
CERESINQ1LS2UJO3AIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MICAV8A1AW0880IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2fd24cc7-5006-1117-e054-00144ff88e882fd24cc7-5007-1117-e054-00144ff88e882016-04-06WarningsExact identifier
spl id: 2fd24cc7-5006-1117-e054-00144ff88e88
spl set id: 2fd24cc7-5007-1117-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.