Owen Biosciences Drug Facts Anhydrous Spf 30

SPL v2

SPL

SPL Set ID 6f56e04f-6d90-41e4-976e-e2e98dfbc98c

Route

TOPICAL

Published

Effective Date 2009-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (10.2 g) Zinc Oxide (3.7 g)

Inactive Ingredients

Cyclomethicone Tribehenin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-09-01

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. Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

Indications and Usage

Directions

Apply evenly before sun exposure and as

needed. For children under 6 months of age: 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 Prevent 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

Structured Label Content

Indications and Usage (34067-9)

Directions

Apply evenly before sun exposure and as

needed. For children under 6 months of age: 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. 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 Prevent 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

Advanced Ingredient Data

[{"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBEHENIN", "unii": "8OC9U7TQZ0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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 evenly before sun exposure and as needed. For children under 6 months of age: 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. 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 Prevent 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:12.283024 · Updated: 2026-03-14T23:00:33.718954