FDA.reportPublic FDA data

PRIDEFUL SPF 15 LIP BALM-passion fruit

Manufacturer
PRIDEFUL LLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:07

Label at a glance#

ProductPRIDEFUL SPF 15 LIP BALM-passion fruit
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure; Use a water resistant sunscreen if swimming or swimming or sweating Reapply at least every 2 hours; Children under 6 month: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10% Octisalate 5%

Octocrylene 3% Avobenzone 2%

Purpose

OTC - PURPOSE SECTION

Susncreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunrbun, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and 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

  • Apply liberally 15 minutes before sun exposure;
  • Use a water resistant sunscreen if swimming or swimming or sweating
  • Reapply at least every 2 hours;
  • Children under 6 month: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexyl Palmitate, Mineral Oil, Polybutene, Hydroxystearic Acid, Ethylene/Propylene/Styrene Copolymer, Stearic Acid, Fragrance, Stevioside, Palmitic Acid, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus, Amygdalus Dulcis (Sweet Almond) Oil, Red 27 Lake, Blue 1 Lake, Palmitate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6Label6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82866-005-00PRIDEFUL SPF 15 LIP BALM-passion fruit3 g in 1 TUBESTICK32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82866-005PRIDEFUL SPF 15 LIP BALM-PASSION FRUIT (HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) STICK [PRIDEFUL LLC]2Current NDC, Legacy NDC, 1 package rows20231027_d6b6389b-c8bd-4aca-8ccf-455dbc22070d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82866-00582866-005-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL PALMITATE2865993309IACT
MINERAL OILT5L8T28FGPIACT
12-HYDROXYSTEARIC ACID933ANU3H2SIACT
ETHYLENE91GW059KN7IACT
PROPYLENEAUG1H506LYIACT
STEARIC ACID4ELV7Z65APIACT
STEVIOSIDE0YON5MXJ9PIACT
PALMITIC ACID2V16EO95H1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
JOJOBA OIL724GKU717MIACT
ALMOND OIL66YXD4DKO9IACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
PRIDEFUL SPF 15 LIP BALM-passion fruitHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCd6b6389b-c8bd-4aca-8ccf-455dbc22070d2023-10-26WarningsExact identifier
ndc (package): 82866-005-00
ndc (product): 82866-005
ndc11 (package): 82866000500
spl id: 089fcbdc-abce-8534-e063-6394a90a2923
spl set id: d6b6389b-c8bd-4aca-8ccf-455dbc22070d

Reported adverse events (FAERS/openFDA)#

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