87283-001-01 Face Spf 47 Setting

SPL v1

SPL

SPL Set ID 47db9a54-c02f-d2ea-e063-6394a90ab973

Route

TOPICAL

Published

Effective Date 2026-01-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octocrylene (3 g) Avobenzone (5 g) Octisalate (8 g) Homosalate

Inactive Ingredients

.alpha.-tocopherol Alcohol Hyaluronic Acid Eucalyptus Globulus Leaf Melaleuca Alternifolia Leaf Sunflower Oil Cyclomethicone 6 Niacinamide Peppermint Cyclomethicone 5 Ethylhexyl Palmitate Ascorbic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-08

Description

Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%

Medication Information

Warnings and Precautions

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.

Indications and Usage

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Dosage and Administration

•Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Description

Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Dosage and Administration (34068-7)

•Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Warnings and Precautions (34071-1)

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONIC ACID", "unii": "S270N0TRQY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS GLOBULUS LEAF", "unii": "S546YLW6E6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MELALEUCA ALTERNIFOLIA LEAF", "unii": "G43C57162K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 6", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.", "34068-7": "•Apply to face 15 minutes before sun exposure. Reapply every 2 hours.", "34071-1": "For External Use Only. Do not use on damaged or broken skin. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.", "50565-1": "Keep out of reach of children.", "51727-6": "Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate", "55105-1": "Sunscreen", "55106-9": "Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:09.014977 · Updated: 2026-03-14T23:12:18.638181