Prideful Spf 15 Lip Balm-passion Fruit

Prideful Spf 15 Lip Balm-passion Fruit
SPL v2
SPL
SPL Set ID d6b6389b-c8bd-4aca-8ccf-455dbc22070d
Route
TOPICAL
Published
Effective Date 2022-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Octocrylene (30 mg) Avobenzone (20 mg)
Inactive Ingredients
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. 27 Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-28
Description

Homosalate 10% Octisalate 5% Octocrylene 3% Avobenzone 2%

Purpose

Susncreen

Medication Information

Purpose

Susncreen

Description

Homosalate 10% Octisalate 5% Octocrylene 3% Avobenzone 2%

Use

Helps prevent sunburn.

Warnings

For external use only.

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.
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

Drug Facts

Other Information

Protect this product from excessive heat and direct sunlight.

Package Labeling:

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, Red 27 Lake, Blue 1 Lake, Palmitate

Stop Use and Ask Doctor

if rash occurs.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Active Ingredients (w/w)

Homosalate 10% Octisalate 5%

Octocrylene 3% Avobenzone 2%

Keep Out of Reach of Children

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

Structured Label Content

Use

Helps prevent sunburn.

Purpose

Susncreen

Warnings

For external use only.

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.
Do Not Use (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

Drug Facts

Other Information (Other information)

Protect this product from excessive heat and direct sunlight.

Package Labeling:

Inactive Ingredients (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, Red 27 Lake, Blue 1 Lake, Palmitate

Stop Use and Ask Doctor (Stop use and ask doctor)

if rash occurs.

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Active Ingredients (w/w) (Active ingredients (w/w))

Homosalate 10% Octisalate 5%

Octocrylene 3% Avobenzone 2%

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.268290 · Updated: 2026-03-14T23:01:33.532889