spf30 sunblock stick

SPL v3

SPL

SPL Set ID e9f963ee-a98c-efc1-e053-2a95a90aaf53

Route

topical

Published

Effective Date 2022-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

octocrylene (4 g) avobenzone (1.5 g) homosalate (2 g) octisalate

Inactive Ingredients

mineral oil ceresin butylated hydroxytoluene ethylhexyl palmitate microcrystalline wax phenoxyethanol petrolatum yellow wax

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2022-10-01

Purpose

Sunscreen

Description

Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%

Medication Information

Warnings

For external use only.

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.

Purpose

Sunscreen

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Description

Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Section 51945-4

Active Ingredient

Avobenzone 1.5%

Homosalate 4%

Octisalate 2%

Octocrylene 4%

Other Information:

Store at 20-25 ^oC (68-77 ^oF).

Inactive Ingredients:

Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

Structured Label Content

Warnings

For external use only.

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.

Purpose

Sunscreen

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Avobenzone 1.5%

Homosalate 4%

Octisalate 2%

Octocrylene 4%

Other Information: (Other information:)

Store at 20-25 ^oC (68-77 ^oF).

Inactive Ingredients: (Inactive ingredients:)

Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

Advanced Ingredient Data

[{"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "Purpose": "Sunscreen", "Warnings": "For external use only.", "Directions": "Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.", "Active ingredient": "Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%", "Other information:": "Store at 20-25 o C (68-77 o F).", "Inactive ingredients:": "Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.789200 · Updated: 2026-03-14T23:05:29.389553