Spf30 Sunscreen Lotion (non Broad Spectrum)

SPL v1

SPL

SPL Set ID 092bafd9-8c27-56df-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2012-03-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octisalate (4 mg) Oxybenzone (5.5 mg) Octocrylene (7 mg) Octinoxate (6.5 mg)

Inactive Ingredients

Methylparaben Propylparaben Water Magnesium Disodium Edta Hypromellose 2208 (100 Mpa.s) Diazolidinyl Urea Ppg-15 Stearyl Ether Benzoate Cupric Triethanolamine

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-08-01

Description

Directions : Apply liberally and evenly 15 minutes before sun exposure. Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel dry9ing. For use on children under 6 months: consult a physician

Medication Information

Warnings and Precautions

WARNINGS : Skin Cancer/ Sking Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

For external use only. Do not use on damaged or broken skin.

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops or persists.

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Indications and Usage

Uses : Helps prevent sunburn.

Dosage and Administration

Directions : Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel dry9ing.

For use on children under 6 months: consult a physician

Description

Section 50565-1

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water

Section 51945-4

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

Structured Label Content

Indications and Usage (34067-9)

Uses : Helps prevent sunburn.

Dosage and Administration (34068-7)

Directions : Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel dry9ing.

For use on children under 6 months: consult a physician

Warnings and Precautions (34071-1)

WARNINGS : Skin Cancer/ Sking Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

For external use only. Do not use on damaged or broken skin.

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops or persists.

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

Advanced Ingredient Data

[{"name": "Octisalate", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Oxybenzone", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "5.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Octocrylene", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Octinoxate", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM DISODIUM EDTA", "unii": "NDT563S5VZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (100 MPA.S)", "unii": "B1QE5P712K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PPG-15 STEARYL ETHER BENZOATE", "unii": "80D2J6361M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CUPRIC TRIETHANOLAMINE", "unii": "6NU949U74E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses : Helps prevent sunburn.", "34068-7": "Directions : Apply liberally and evenly 15 minutes before sun exposure. Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel dry9ing. For use on children under 6 months: consult a physician", "34071-1": "WARNINGS : Skin Cancer/ Sking Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging. For external use only. Do not use on damaged or broken skin. When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove. Stop use and ask a doctor if irritation or rash develops or persists. Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.", "50565-1": "Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.", "51727-6": "Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water", "55105-1": "Purpose: Sunscreen", "55106-9": "Active Ingredients: Octocrylene 7%, Octinoxate 6.5% Oxybenone 5.5 %, Octisalate 4%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.284355 · Updated: 2026-03-14T22:54:41.714370