84938-005 Sunscreen Stick

84938-005 Sunscreen Stick
SPL v1
SPL
SPL Set ID 460e1038-30f0-a6e4-e063-6394a90ad534
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.08 g) Homosalate (0.06 g) Zinc Oxide (0.15 g)
Inactive Ingredients
Tocopherol Octisalate Polyhydroxystearic Acid (2300 Mw) Candelilla Wax Microcrystalline Wax Beeswax Hydrogenated Coconut Oil Cocoyl Caprylocaprate Shea Butter Phenylpropanol Silica Caprylyl Glycol Caprylic/capric Triglyceride Alkyl (c12-15) Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16

Description

Zinc Oxide 15%, Titanium Dioxide 8%, Homosalate 6%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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.

Dosage and Administration

Directions apply liberally 15 minutes before sun exposure reapply:after 80 minutes of swimming or sweating . lmmediately after towel drying ·at least every 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 a sunscreen with a broad spectrum SPF value 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

Description

Zinc Oxide 15%, Titanium Dioxide 8%, Homosalate 6%

Section 50565-1

Keep out ofreach ofchildren. lf product is swallowed, get medical help or contact a Poison Control Center right away.May stain some fabrics.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Candelilla Wax

Microcrystalline Wax

Beeswax

Hydrogenated Coconut Oil

Caprylic/Capric Triglyceride

Coco‑Caprylate/Caprate

C12‑15 Alkyl Benzoate

Octisalate (Ethylhexyl Salicylate)

Polyhydroxystearic Acid

Shea Butter (Butyrospermum Parkii Butter)

Tocopherol

Caprylyl Glycol

Phenylpropanol

Silica

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 15%, Titanium Dioxide 8%, Homosalate 6%


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions apply liberally 15 minutes before sun exposure reapply:after 80 minutes of swimming or sweating . lmmediately after towel drying ·at least every 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 a sunscreen with a broad spectrum SPF value 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

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out ofreach ofchildren. lf product is swallowed, get medical help or contact a Poison Control Center right away.May stain some fabrics.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Candelilla Wax

Microcrystalline Wax

Beeswax

Hydrogenated Coconut Oil

Caprylic/Capric Triglyceride

Coco‑Caprylate/Caprate

C12‑15 Alkyl Benzoate

Octisalate (Ethylhexyl Salicylate)

Polyhydroxystearic Acid

Shea Butter (Butyrospermum Parkii Butter)

Tocopherol

Caprylyl Glycol

Phenylpropanol

Silica

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 15%, Titanium Dioxide 8%, Homosalate 6%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)