84938-013 Sunscreen Lotion

84938-013 Sunscreen Lotion
SPL v1
SPL
SPL Set ID 46355437-4068-9d03-e063-6394a90ae52c
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.06 g) Octisalate (0.04 g) Zinc Oxide (0.15 g) Homosalate (0.05 g)
Inactive Ingredients
C12-15 Alkyl Benzoate Coco-caprylate/caprate Glyceryl Stearate Citrate Xanthan Gum Caprylic/capric Triglyceride Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-6 Distearate Cetearyl Alcohol Sodium Pca Tocopherol Caprylyl Glycol Phenylpropanol Aqua Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-18

Description

Zinc Oxide 15%,Titanium Dioxide 6%,Homosalate 5%, Octisalate 4%


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 m reapply: after 80 minutes of swimming or sweating "lmmediately after towel drying "at least every 2 hours m Sun Protection Measures. Spending time in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and othersun 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 6%,Homosalate 5%, Octisalate 4%

Section 50565-1



Keep out of reach of children. 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

Aqua (Water)

Caprylic/Capric Triglyceride

C12‑15 Alkyl Benzoate

Coco‑Caprylate/Caprate

Polyhydroxystearic Acid

Glyceryl Stearate Citrate

Cetearyl Alcohol

Polyglyceryl‑6 Distearate

Glycerin

Sodium PCA

Tocopherol (Vitamin E)

Caprylyl Glycol

Phenylpropanol

Xanthan Gum

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 15%,Titanium Dioxide 6%,Homosalate 5%, Octisalate 4%


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 m reapply: after 80 minutes of swimming or sweating "lmmediately after towel drying "at least every 2 hours m Sun Protection Measures. Spending time in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and othersun 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 of reach of children. 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)

Aqua (Water)

Caprylic/Capric Triglyceride

C12‑15 Alkyl Benzoate

Coco‑Caprylate/Caprate

Polyhydroxystearic Acid

Glyceryl Stearate Citrate

Cetearyl Alcohol

Polyglyceryl‑6 Distearate

Glycerin

Sodium PCA

Tocopherol (Vitamin E)

Caprylyl Glycol

Phenylpropanol

Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 15%,Titanium Dioxide 6%,Homosalate 5%, Octisalate 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)