84938-012 Sunscreen Cream

84938-012 Sunscreen Cream
SPL v1
SPL
SPL Set ID 46224dbe-a0fb-c242-e063-6394a90a2634
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.05 g) Octisalate (0.04 g) Zinc Oxide (0.15 g) Titanium Dioxide (0.06 g)
Inactive Ingredients
Triethoxycaprylylsilane Sodium Hyaluronate Cetearyl Alcohol Aqua Stearic Acid Aluminum Hydroxide Dimethicone Glycerin Ammonium Acryloyldimethyltaurate/vp Copolymer Caprylic/capric Triglyceride Ethylhexylglycerin Phenoxyethanol Hydroxyacetophenone Glyceryl Stearate

Identifiers & Packaging

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

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 reapply: after 80 minutes of swimming or sweatingImmediately after towel drying "at least every 2 hours SunProtection Measures. Spending time in the sun increases yourrisk 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 children under 6 months:shirts, pants, hats, and sunglassesAsk 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

Dimethicone

Glycerin

Sodium Hyaluronate (Hydrolyzed)

Glyceryl Stearate

Cetearyl Alcohol

Ammonium Acryloyldimethyltaurate/VP Copolymer

Phenoxyethanol

Ethylhexyl Glycerin

Hydroxyacetophenone

Aluminum Hydroxide

Stearic Acid

Triethoxycaprylylsilane

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 reapply: after 80 minutes of swimming or sweatingImmediately after towel drying "at least every 2 hours SunProtection Measures. Spending time in the sun increases yourrisk 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 children under 6 months:shirts, pants, hats, and sunglassesAsk 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

Glycerin

Sodium Hyaluronate (Hydrolyzed)

Glyceryl Stearate

Cetearyl Alcohol

Ammonium Acryloyldimethyltaurate/VP Copolymer

Phenoxyethanol

Ethylhexyl Glycerin

Hydroxyacetophenone

Aluminum Hydroxide

Stearic Acid

Triethoxycaprylylsilane

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

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