Sfl Sunscreen - Sol Defense

SPL v7

SPL

SPL Set ID 4382d55d-1463-41e3-9805-4125055b2e42

Route

TOPICAL

Published

Effective Date 2019-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (17.5 g) Zinc Oxide (1 g)

Inactive Ingredients

Cyclomethicone Tribehenin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-09-11

Description

Active ingredients Purpose Titanium Dioxide 10.20% Sunscreen Zinc Oxide 3.70% Sunscreen

Medication Information

Warnings and Precautions

Warnings

For external use only. When using this product keep

out of eyes. Rinse with water to remove. Stop use and

ask doctor if rash and irritation develops and lasts.

Avoid contact with eyes. If product gets into eyes,

rinse thoroughly with water.

Keep out of reach of children. If swallowed, get

medical help or contact poison control center right

away.

Indications and Usage

Directions

Apply generously before sun exposure and as

needed. For children under 6 months, ask a doctor.

Reapply as needed or after towel drying, swimming

or perspiring.

Description

Active ingredients Purpose Titanium Dioxide 10.20% Sunscreen Zinc Oxide 3.70% Sunscreen

Section 34076-0

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

Section 51727-6

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

Section 51945-4

Section 55105-1

USES

Helps protect against sunburn

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Drug Facts

Active ingredients Purpose

Titanium Dioxide 10.20% Sunscreen

Zinc Oxide 3.70% Sunscreen

Dosage & Administration

Apply generously before sun exposure and as

needed. For children under 6 months, ask a doctor.

Reapply as needed or after towel drying, swimming

or perspiring.

Keep Out of Reach of Children

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

Structured Label Content

Indications and Usage (34067-9)

Directions

Apply generously before sun exposure and as

needed. For children under 6 months, ask a doctor.

Reapply as needed or after towel drying, swimming

or perspiring.

Warnings and Precautions (34071-1)

Warnings

For external use only. When using this product keep

out of eyes. Rinse with water to remove. Stop use and

ask doctor if rash and irritation develops and lasts.

Avoid contact with eyes. If product gets into eyes,

rinse thoroughly with water.

Keep out of reach of children. If swallowed, get

medical help or contact poison control center right

away.

Section 34076-0 (34076-0)

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

Section 51727-6 (51727-6)

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

USES

Helps protect against sunburn

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Drug Facts

Active ingredients Purpose

Titanium Dioxide 10.20% Sunscreen

Zinc Oxide 3.70% Sunscreen

Dosage & Administration

Apply generously before sun exposure and as

needed. For children under 6 months, ask a doctor.

Reapply as needed or after towel drying, swimming

or perspiring.

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

[{"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "17.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TRIBEHENIN", "unii": "8OC9U7TQZ0", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "0.09", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "10.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "3.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions Apply generously before sun exposure and as needed. For children under 6 months, ask a doctor. Reapply as needed or after towel drying, swimming or perspiring.", "34071-1": "Warnings For external use only . When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children . If swallowed, get medical help or contact poison control center right away.", "34076-0": "Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.", "51727-6": "Inactive Ingredients Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.", "55105-1": "USES Helps protect against sunburn Higher SPF gives more sunburn protection Provides moderate protection against sunburn.", "Drug Facts": "Active ingredients Purpose Titanium Dioxide 10.20% Sunscreen Zinc Oxide 3.70% Sunscreen", "Dosage & Administration": "Apply generously before sun exposure and as needed. For children under 6 months, ask a doctor. Reapply as needed or after towel drying, swimming or perspiring.", "Keep out of reach of children": "Keep out of reach of children. If swallowed get medical help or call Poison Control right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:18.436882 · Updated: 2026-03-14T23:06:55.199519