PRIDEFUL SPF 15 LIP BALM-COCONUT- homosalate, octisalate, octocrylene, avobenzone stick

PRIDEFUL SPF 15 LIP BALM-coconut by

Drug Labeling and Warnings

PRIDEFUL SPF 15 LIP BALM-coconut by is a Otc medication manufactured, distributed, or labeled by PRIDEFUL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (w/w)

Homosalate 10% Octisalate 5%

Octocrylene 3% Avobenzone 2%

Purpose

Susncreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use

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

Keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

if rash occurs.

Keep out of reach of children

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

Directions

• 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

Protect this product from excessive heat and direct sunlight.

Inactive ingredients

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, blue 1 lake, Palmitate

Package Labeling:

INGREDIENTS AND APPEARANCE

PRIDEFUL SPF 15 LIP BALM-COCONUT 
homosalate, octisalate, octocrylene, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82866-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MINERAL OIL (UNII: T5L8T28FGP)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
ETHYLENE (UNII: 91GW059KN7)
PROPYLENE (UNII: AUG1H506LY)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEVIOSIDE (UNII: 0YON5MXJ9P)
PALMITIC ACID (UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
ALMOND OIL (UNII: 66YXD4DKO9)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82866-002-00	3 g in 1 TUBE; Type 0: Not a Combination Product	07/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/28/2022

Labeler - PRIDEFUL LLC (118596264)