Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ed883d63-777c-e924-e053-2995a90a162a
Route
TOPICAL
Published
Effective Date 2022-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.7 g) Zinc Oxide (6 g)
Inactive Ingredients
Cyclomethicone 6 Dimethicone/polyglycerin-3 Crosspolymer Stearic Acid Sodium Chloride Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Polyglyceryl-4 Isostearate Phenoxyethanol Orange Oil Ferric Oxide Red Benzoic Acid Tocopherol Agathosma Betulina Leaf Oil Magnesium Oxide Sodium Succinate Anhydrous Potassium Sorbate Sodium Benzoate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sodium Ferrocyanide Green Tea Leaf Water Cyclomethicone 5 Glycerin Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Aluminum Hydroxide Mandarin Oil Tetrahexyldecyl Ascorbate Pea Protein Ferrosoferric Oxide Lecithin, Soybean Ergothioneine Hexyl Laurate Caprylyl Glycol Sorbitan Olivate Aluminum Oxide Dimethicone/peg-10/15 Crosspolymer Sunflower Oil Laminaria Digitata .alpha.-tocopherol Acetate Hexylene Glycol Artemisia Vulgaris Root Sodium Citrate Micrococcus Luteus Dimethicone Alkyl (c12-15) Benzoate Ferric Oxide Yellow Limonene, (+)- Arabidopsis Thaliana Dipropylene Glycol Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ethylhexylglycerin Anhydrous Dextrose Cetearyl Olivate Vanilla Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-15
Description

Active ingredients Titanium Dioxide 4.7% Zinc Oxide 6.0%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Indication and usage

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

Dosage and Administration

Directions

apply generously 15 minutes before sun exposure

children under 6 months of age: Ask a doctor

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Description

Active ingredients Titanium Dioxide 4.7% Zinc Oxide 6.0%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients AQUA/WATER/EAU, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CYCLOHEXASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, STEARIC ACID, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, IRON OXIDES (CI 77492), LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SORBITAN OLIVATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, TOCOPHERYL ACETATE, IRON OXIDES (CI 77491), CAMELLIA SINENSIS LEAF EXTRACT, IRON OXIDES (CI 77499), BENZOIC ACID, DIPROPYLENE GLYCOL, TITANIUM DIOXIDE (CI 77891), ARTEMISIA VULGARIS EXTRACT, LAMINARIA DIGITATA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, TRIETHOXYCAPRYLYLSILANE, SODIUM CITRATE, GLUCOSE, HYDROLYZED PEA PROTEIN, TOCOPHEROL, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, ALUMINA, MAGNESIUM OXIDE, SODIUM SUCCINATE, POTASSIUM SORBATE, SODIUM BENZOATE, LECITHIN, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Titanium Dioxide 4.7%

Zinc Oxide 6.0%

Section 60561-8

protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Indication and usage

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

Dosage and Administration (34068-7)

Directions

apply generously 15 minutes before sun exposure

children under 6 months of age: Ask a doctor

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients AQUA/WATER/EAU, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CYCLOHEXASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, STEARIC ACID, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, IRON OXIDES (CI 77492), LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SORBITAN OLIVATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, TOCOPHERYL ACETATE, IRON OXIDES (CI 77491), CAMELLIA SINENSIS LEAF EXTRACT, IRON OXIDES (CI 77499), BENZOIC ACID, DIPROPYLENE GLYCOL, TITANIUM DIOXIDE (CI 77891), ARTEMISIA VULGARIS EXTRACT, LAMINARIA DIGITATA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, TRIETHOXYCAPRYLYLSILANE, SODIUM CITRATE, GLUCOSE, HYDROLYZED PEA PROTEIN, TOCOPHEROL, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, ALUMINA, MAGNESIUM OXIDE, SODIUM SUCCINATE, POTASSIUM SORBATE, SODIUM BENZOATE, LECITHIN, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Titanium Dioxide 4.7%

Zinc Oxide 6.0%

Section 60561-8 (60561-8)

protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:41.322343 · Updated: 2026-03-14T23:05:37.016425