PRIDEFUL SPF 15 LIP BALM-orange mango

Manufacturer: PRIDEFUL LLC
Effective date: 2023-10-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:58:04

Label at a glance#

ProductPRIDEFUL SPF 15 LIP BALM-orange mango

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 6 Lake, Yellow 10 Lake, Palmitate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82866-004-00	PRIDEFUL SPF 15 LIP BALM-orange mango	3 g in 1 TUBE	STICK	3		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82866-004	PRIDEFUL SPF 15 LIP BALM-ORANGE MANGO (HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) STICK [PRIDEFUL LLC]	2	Current NDC, Legacy NDC, 1 package rows	20231027_c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf.zip

Products#

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

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

PRIDEFUL SPF 15 LIP BALM-orange mango
HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
D&C YELLOW NO. 10
ETHYLHEXYL PALMITATE
MINERAL OIL
12-HYDROXYSTEARIC ACID
ETHYLENE
PROPYLENE
STEARIC ACID
STEVIOSIDE
PALMITIC ACID
.ALPHA.-TOCOPHEROL ACETATE
JOJOBA OIL
ALMOND OIL
D&C RED NO. 6
HOMOSALATE
OCTISALATE
OCTOCRYLENE
AVOBENZONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82866-004	82866-004-00

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
Name	UNII	Kind
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
MINERAL OIL	T5L8T28FGP	IACT
12-HYDROXYSTEARIC ACID	933ANU3H2S	IACT
ETHYLENE	91GW059KN7	IACT
PROPYLENE	AUG1H506LY	IACT
STEARIC ACID	4ELV7Z65AP	IACT
STEVIOSIDE	0YON5MXJ9P	IACT
PALMITIC ACID	2V16EO95H1	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
JOJOBA OIL	724GKU717M	IACT
ALMOND OIL	66YXD4DKO9	IACT
D&C RED NO. 6	481744AI4O	IACT
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIDEFUL SPF 15 LIP BALM-orange mango	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf	2023-10-26	Warnings	Exact identifier ndc (package): 82866-004-00 ndc (product): 82866-004 ndc11 (package): 82866000400 spl id: 089fcdb1-9821-b024-e063-6394a90a26d5 spl set id: c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf

Reported adverse events (FAERS/openFDA)#

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