FDA.reportPublic FDA data

Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30

Manufacturer
Dr Pawpaw Limited
Effective date
2024-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:05

Label at a glance#

ProductDr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure7 sections

Indications and 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.

Dosage and administration

When using this product  Apply liberally 15 minutes before sun exposure. children under 6 months of age: Ask a doctor Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 7%

Octocrylene 7%

Homosalate 7%

Octisalate 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Stop use & ask doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

When using this product 

Apply liberally 15 minutes before sun exposure. children under 6 months of age: Ask a doctor Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Hydroxystearic Acid, Candelilla Cera, Olea Europaea (Olive) Fruit Oil, Parfum (Fragrance), Stearic Acid, Palmitic Acid, Carica Papaya (Papaya) Fruit Extract, Limonene, Aloe Barbadensis Leaf Extract.

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label01.jpgLabel01.jpgInner Label.jpgInner Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84572-000-01Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 308 mL in 1 TUBECREAM81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84572-000DR PAWPAW MULTIPURPOSE LIP BALM WITH NATURAL PAWPAW AND SPF 30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE) CREAM [DR PAWPAW LIMITED]1Current NDC, 1 package rows20240726_f2628e3e-9eb0-49cb-91a6-d15c48cb8a19.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84572-00084572-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
SUNFLOWER OIL3W1JG795YIIACT
12-HYDROXYSTEARIC ACID933ANU3H2SIACT
CANDELILLA WAXWL0328HX19IACT
OLIVE OIL6UYK2W1W1EIACT
STEARIC ACID4ELV7Z65APIACT
PALMITIC ACID2V16EO95H1IACT
PAPAYAKU94FIY6JBIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATEDr Pawpaw Limitedf2628e3e-9eb0-49cb-91a6-d15c48cb8a192024-07-25WarningsExact identifier
ndc (package): 84572-000-01
ndc (product): 84572-000
ndc11 (package): 84572000001
spl id: 1e16a8a5-519b-ee20-e063-6394a90ab05b
spl set id: f2628e3e-9eb0-49cb-91a6-d15c48cb8a19

Reported adverse events (FAERS/openFDA)#

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