Highlighter Body Spf 50 (85624-001-15)

Highlighter Body Spf 50 (85624-001-15)
SPL v1
SPL
SPL Set ID 3d4c90e7-0716-4d57-e063-6394a90a43fa
Route
TOPICAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Homosalate (15 g) Octocrylene (10 g) Avobenzone (3 g)
Inactive Ingredients
Ethylhexyl Palmitate Psidium Guajava Fruit Caprylic/capric Triglyceride Cocos Nucifera (coconut) Oil Diethylhexyl 2,6-naphthalate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Tocopherol Apricot Kernel Oil Butyloctyl Salicylate Dextrin Palmitate (corn; 20000 Mw) Silica Diethylhexyl Syringylidenemalonate Helianthus Annuus (sunflower) Seed Oil Titanium Dioxide Ci 77491 Citrullus Lanatus (watermelon) Seed Oil Magnesium Potassium Aluminosilicate Fluoride Ananas Sativus (pineapple) Fruit Theobroma Cacao (cocoa) Seed Powder Tin Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.

Section 50570-1

on damaged skin or broken skin

Section 51945-4

Warnings

For external use only

Directions

• Shake well before use. Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is covered. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least ever 2 hours.

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: ask a doctor.

Drug Facts

Drug Facts

Questions?

Contact (609) 320-4845

Other Information

Protect the product from excessive heat and direct sun.

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients

ETHYLHEXYL PALMITATE, DIETHYLHEXYL 2,6-NAPHTHALATE, BUTYLOCTYL SALICYLATE, POLYESTER-8, DEXTRIN PALMITATE, SILICA, DIETHYLHEXYL SYRINGYLIDENEMALONATE, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, SYNTHETIC FLUORPHLOGOPITE, CITRULLUS LANATUS (WATERMELON) SEED OIL, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CI 77891 (TITANIUM DIOXIDE), COCOS NUCIFERA (COCONUT) OIL, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, PSIDIUM GUAJAVA FRUIT EXTRACT, THEOBROMA CACAO (COCOA) SEED EXTRACT, CI 77491 (IRON OXIDES), TIN OXIDE.

When Using This Product

keep out of eyes. Rince with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

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

Structured Label Content

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.

Section 50570-1 (50570-1)

on damaged skin or broken skin

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

• Shake well before use. Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is covered. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least ever 2 hours.

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: ask a doctor.

Drug Facts

Drug Facts

Questions?

Contact (609) 320-4845

Other Information (Other information)

Protect the product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

ETHYLHEXYL PALMITATE, DIETHYLHEXYL 2,6-NAPHTHALATE, BUTYLOCTYL SALICYLATE, POLYESTER-8, DEXTRIN PALMITATE, SILICA, DIETHYLHEXYL SYRINGYLIDENEMALONATE, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, SYNTHETIC FLUORPHLOGOPITE, CITRULLUS LANATUS (WATERMELON) SEED OIL, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CI 77891 (TITANIUM DIOXIDE), COCOS NUCIFERA (COCONUT) OIL, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, PSIDIUM GUAJAVA FRUIT EXTRACT, THEOBROMA CACAO (COCOA) SEED EXTRACT, CI 77491 (IRON OXIDES), TIN OXIDE.

When Using This Product (When using this product)

keep out of eyes. Rince with water to remove.

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

if rash occurs

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: 2026-02-15T12:08:00.419621 · Updated: 2026-03-14T23:12:06.957806