84938-011 Sunscreen Lotion

84938-011 Sunscreen Lotion
SPL v1
SPL
SPL Set ID 4620c41a-2188-00f5-e063-6394a90a613c
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.06 g) Homosalate (0.14 g) Octisalate (0.05 g) Zinc Oxide (0.12 g)
Inactive Ingredients
Triethoxycaprylylsilane Aluminum Hydroxide Xanthan Gum Cetearyl Alcohol Stearic Acid Isohexadecane .alpha.-tocopherol Acetate Glyceryl Stearate Citrate Sodium Hyaluronate Phenoxyethanol Ethylhexylglycerin Dimethicone Butylene Glycol Glycerin Ammonium Acryloyldimethyltaurate/vp Copolymer Caprylic/capric Triglyceride Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

Description

Zinc Oxide 12%,Titanium Dioxide 6%, Homosalate 14%,Octisalate 5%


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 skinaging. 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 shirtspants, hats,and sunglasses children under 6 months.Ask a doctor

Description

Zinc Oxide 12%,Titanium Dioxide 6%, Homosalate 14%,Octisalate 5%

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

Dimethicone

Isohexadecane

Cetearyl Alcohol

Glyceryl Stearate Citrate

Triethoxycaprylylsilane

Stearic Acid

Aluminum Hydroxide

Glycerin

Butylene Glycol

Sodium Hyaluronate (Hydrolyzed)

Ammonium Acryloyldimethyltaurate/VP Copolymer

Phenoxyethanol

Ethylhexyl Glycerin

Tocopheryl Acetate

Xanthan Gum

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 12%,Titanium Dioxide 6%, Homosalate 14%,Octisalate 5%


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 skinaging. 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 shirtspants, 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

Dimethicone

Isohexadecane

Cetearyl Alcohol

Glyceryl Stearate Citrate

Triethoxycaprylylsilane

Stearic Acid

Aluminum Hydroxide

Glycerin

Butylene Glycol

Sodium Hyaluronate (Hydrolyzed)

Ammonium Acryloyldimethyltaurate/VP Copolymer

Phenoxyethanol

Ethylhexyl Glycerin

Tocopheryl Acetate

Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 12%,Titanium Dioxide 6%, Homosalate 14%,Octisalate 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)