Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID eb8e7109-b5eb-5cc1-e053-2995a90a486f
Route
TOPICAL
Published
Effective Date 2022-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.7 g) Titanium Dioxide (6.5 g)
Inactive Ingredients
Alkyl (c12-15) Benzoate Dimethicone Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sunflower Oil Hexylene Glycol Mandarin Oil Sorbitan Olivate Agathosma Betulina Leaf Oil Stearic Acid Sodium Chloride Hexyl Laurate Peg/ppg-18/18 Dimethicone Ethylhexyl Palmitate .alpha.-tocopherol Acetate Tocopherol Benzoic Acid Dipropylene Glycol Propylene Glycol Butylene Glycol Vanilla Sodium Citrate Ascorbyl Palmitate Pentylene Glycol Citric Acid Monohydrate Polygonum Aviculare Top Caesalpinia Spinosa Fruit Pod Sodium Lactate Sodium Ferrocyanide Polysorbate 20 Vitis Vinifera Anthocyanins Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 Polyglyceryl-4 Isostearate Dimethicone/peg-10/15 Crosspolymer Aluminum Hydroxide Helianthus Annuus Sprout Polyethylene Glycol 400 Dimethicone/polyglycerin-3 Crosspolymer Ethylhexylglycerin Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Orange Oil Limonene, (+)- Caprylyl Glycol Cyclomethicone 5 Water Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Phenoxyethanol Carbomer Homopolymer, Unspecified Type Isomalt Silica Dimethyl Silylate Ascorbic Acid Sodium Benzoate Hyaluronate Sodium Lecithin, Soybean Potassium Sorbate Cyclomethicone 6 Cetearyl Olivate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-21
Description

Active ingredients Titanium Dioxide 6.5% Zinc Oxide 8.7%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

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 increase 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 inducing: • limit time in the sun, especially from 10 am.-2 p.m. • wear long-sleeved shits, pants, hats and sunglasses

Description

Active ingredients Titanium Dioxide 6.5% Zinc Oxide 8.7%

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 Ingredient:

CYCLOPENTASILOXANE, AQUA/WATER/EAU, C12-15 ALKYL BENZOATE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, PEG/PPG-18/18 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, CYCLOHEXASILOXANE, SORBITAN OLIVATE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, PEG-8, TOCOPHERYL ACETATE, TOCOPHEROL, ISOMALT, BENZOIC ACID, DIPROPYLENE GLYCOL, PROPYLENE GLYCOL, BUTYLENE GLYCOL, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CITRATE, ASCORBYL PALMITATE, SILICA DIMETHYL SILYLATE, PENTYLENE GLYCOL, ASCORBIC ACID, CITRIC ACID, POLYGONUM AVICULARE EXTRACT, BAROSMA BETULINA LEAF OIL, CAESALPINIA SPINOSA FRUIT POD EXTRACT, CARBOMER, SODIUM LACTATE, SODIUM BENZOATE, POLYSORBATE 20, SODIUM HYALURONATE, LECITHIN, POTASSIUM SORBATE, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.7%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

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

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 increase 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 inducing: • limit time in the sun, especially from 10 am.-2 p.m. • wear long-sleeved shits, 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 Ingredient:

CYCLOPENTASILOXANE, AQUA/WATER/EAU, C12-15 ALKYL BENZOATE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, PEG/PPG-18/18 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, CYCLOHEXASILOXANE, SORBITAN OLIVATE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, PEG-8, TOCOPHERYL ACETATE, TOCOPHEROL, ISOMALT, BENZOIC ACID, DIPROPYLENE GLYCOL, PROPYLENE GLYCOL, BUTYLENE GLYCOL, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CITRATE, ASCORBYL PALMITATE, SILICA DIMETHYL SILYLATE, PENTYLENE GLYCOL, ASCORBIC ACID, CITRIC ACID, POLYGONUM AVICULARE EXTRACT, BAROSMA BETULINA LEAF OIL, CAESALPINIA SPINOSA FRUIT POD EXTRACT, CARBOMER, SODIUM LACTATE, SODIUM BENZOATE, POLYSORBATE 20, SODIUM HYALURONATE, LECITHIN, POTASSIUM SORBATE, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.7%

Section 60561-8 (60561-8)

Other information • 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: 2026-02-15T12:04:41.318467 · Updated: 2026-03-14T23:05:37.016425