84938-007 Sunscreen Cream

Drug Facts

Composition & Product

Active Ingredients

Phenylbenzimidazole Sulfonic Acid (0.035 g) Zinc Oxide (0.12 g) Titanium Dioxide (0.08 g) Homosalate (0.045 g) Octisalate

Inactive Ingredients

Beeswax Potassium Sorbate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sodium Benzoate Caprylic/capric Triglyceride Hydrogenated Poly(c6-14 Olefin; 2 Cst) Water Citric Acid C12-15 Alkyl Benzoate Glycerin Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-6 Stearate Polyglyceryl-6 Behenate Tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-16

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 Immediately 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 timein 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 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%

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

C12‑15 Alkyl Benzoate

Glycerin

Hydrogenated Poly(C6‑14 Olefin)

Polyhydroxystearic Acid

Polyglyceryl‑3 Polydimethylsiloxyethyl Dimethicone

Polyglyceryl‑6 Stearate

Polyglyceryl‑6 Behenate

Tocopherol

Beeswax

Xanthan Gum

Sodium Benzoate

Potassium Sorbate

Citric Acid

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%

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 Immediately 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 timein 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

C12‑15 Alkyl Benzoate

Glycerin

Hydrogenated Poly(C6‑14 Olefin)

Polyhydroxystearic Acid

Polyglyceryl‑3 Polydimethylsiloxyethyl Dimethicone

Polyglyceryl‑6 Stearate

Polyglyceryl‑6 Behenate

Tocopherol

Beeswax

Xanthan Gum

Sodium Benzoate

Potassium Sorbate

Citric Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%

Advanced Ingredient Data

[{"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)", "unii": "RLA2U05Z4Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLIC/CAPRIC TRIGLYCERIDE", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)", "unii": "P0TX083987", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLBENZIMIDAZOLE SULFONIC ACID", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "0.035", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "0.12", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "0.08", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "0.12", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.045", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-6 STEARATE", "unii": "ETY9Q81E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-6 BEHENATE", "unii": "4T2L7QI313", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "34068-7": "Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating Immediately 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 timein the sun,especially from 10 a.m.-2 p.m."wear long-sleeved children under 6 months: shirts, pants, hats, and sunglassesAsk a doctor", "34071-1": "For external use only.", "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.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "51727-6": "Aqua (Water) Caprylic/Capric Triglyceride C12‑15 Alkyl Benzoate Glycerin Hydrogenated Poly(C6‑14 Olefin) Polyhydroxystearic Acid Polyglyceryl‑3 Polydimethylsiloxyethyl Dimethicone Polyglyceryl‑6 Stearate Polyglyceryl‑6 Behenate Tocopherol Beeswax Xanthan Gum Sodium Benzoate Potassium Sorbate Citric Acid", "55105-1": "Sunscreen", "55106-9": "Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information