SPL v3
SPL
SPL Set ID 29f2e92d-ffde-1de1-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (17977.5 mg) Glycerin (8145.73 mg) Octocrylene (2100 mg)
Inactive Ingredients
Prunus Mume Fruit Gelidium Cartilagineum Squalane Portulaca Oleracea Whole Enzacamene Cyclomethicone 6 Glyceryl Monostearate Peg-100 Stearate Orange Octisalate Cetostearyl Alcohol Chamaemelum Nobile Flower Ulva Compressa Coco Glucoside Vanilla Benzyl Alcohol Glyceryl Caprylate Macrocystis Pyrifera Ecklonia Cava Laminaria Japonica Nymphaea Alba Flower Viscum Album Fruit Potassium Sorbate Sorbitan Sesquioleate Tromethamine Dimethicone Chamaecyparis Obtusa Leaf Sansevieria Trifasciata Leaf Ethylhexylglycerin Dehydroacetic Acid Sodium Benzoate Acetyl Tetrapeptide-15 Water Butylene Glycol Neopentyl Glycol Diheptanoate Aloe Vera Leaf Potassium Cetyl Phosphate Peg-2 Stearate Caprylyl Glycol Ethylhexyl Palmitate Glycol Stearate Phenoxyethanol Lavandula Angustifolia Flower Dipropylene Glycol Sodium Palmitoyl Proline Codium Tomentosum Sorbic Acid Viscum Album Whole Avobenzone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-14
Description

Ethylhexyl Methoxycinnamate 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Ethylhexyl Methoxycinnamate 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

Use

The all-in-one sun helps restore natural tone by providing moisture to the skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Active Ingredients

Ethylhexyl Methoxycinnamate 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

Inactive Ingredients

Water, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Cyclohexasiloxane, Butylene Glycol, Neopentyl Glycol Diheptanoate, Ethylhexyl Salicylate, Polymethyl Methacrylate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Tromethamine, Phenoxyethanol, Glyceryl Caprylate, Fragrance(Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Caprylyl Glycol, Dimethicone, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Polydecene, Dipropylene Glycol, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Sodium Palmitoyl Proline, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Squalane, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Coco-Glucoside, Vanilla Tahitensis Fruit Extract, Benzyl Alcohol, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Sorbic Acid, Ethylhexylglycerin, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Use

The all-in-one sun helps restore natural tone by providing moisture to the skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Purpose

Sunscreen

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Active Ingredients

Ethylhexyl Methoxycinnamate 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

Inactive Ingredients

Water, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Cyclohexasiloxane, Butylene Glycol, Neopentyl Glycol Diheptanoate, Ethylhexyl Salicylate, Polymethyl Methacrylate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Tromethamine, Phenoxyethanol, Glyceryl Caprylate, Fragrance(Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Caprylyl Glycol, Dimethicone, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Polydecene, Dipropylene Glycol, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Sodium Palmitoyl Proline, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Squalane, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Coco-Glucoside, Vanilla Tahitensis Fruit Extract, Benzyl Alcohol, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Sorbic Acid, Ethylhexylglycerin, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate

Principal Display Panel

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

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:03.781263 · Updated: 2026-03-14T22:54:15.762833