Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ef4d54bf-25f5-4261-9d3d-c42b0d892275
Route
TOPICAL
Published
Effective Date 2019-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 mg) Octinoxate (7.5 mg) Oxybenzone (6 mg) Avobenzone (2 mg) Octocrylene (1.5 mg)
Inactive Ingredients
Butyl Cyanoacetate Yeast Echinacea Purpurea Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer Biotin Water Green Tea Leaf Centella Asiatica Cyclomethicone 5 Cyclomethicone 6 Tocopherol Ascorbic Acid Citric Acid Monohydrate Palmitoyl Pentapeptide-4 Darutoside Sodium Benzoate Sodium Metabisulfite Sodium Lactate Xanthan Gum Benzoic Acid Benzyl Alcohol Geraniol Polyethylene Glycol 400 Edetate Disodium Anhydrous Sorbitan Monooleate Ubidecarenone Potassium Sorbate Benzyl Salicylate Linalool, (+/-)- Eugenol Butylene Glycol Octyldodecyl Neopentanoate Medium-chain Triglycerides Glycerin Polygonum Aviculare Top Teprenone Carbomer Homopolymer, Unspecified Type Caesalpinia Spinosa Fruit Pod Helianthus Annuus Sprout Lecithin, Soybean Micrococcus Luteus Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Laminaria Digitata Trolamine Ascorbyl Palmitate Polysorbate 20 Arctostaphylos Uva-ursi Leaf Mitracarpus Hirtus Whole Arabidopsis Thaliana Whole Propylene Glycol Phenoxyethanol Aloe Vera Leaf Carbomer Interpolymer Type A (55000 Cps) Hyaluronate Sodium Kiwi Fruit Artemisia Vulgaris Whole Alkyl (c12-15) Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-15
Description

Active Ingredients: Octinoxate - 7.5% Oxybenzone - 6.0% Octisalate - 5.0% Avobenzone - 2.0% Octocrylene - 1.5%

Medication Information

Warnings and Precautions

Warnings - For external use only.

Indications and Usage

Uses - This product is suited for broad spectrum UV Protection.

Dosage and Administration

Directions - Apply using fingertips 20-30 minutes before sun exposure. Gentely massage into face and neck. Reapply as needed. Discontinue use if irritation develops.

Description

Active Ingredients: Octinoxate - 7.5% Oxybenzone - 6.0% Octisalate - 5.0% Avobenzone - 2.0% Octocrylene - 1.5%

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 severe skin irritation develops.

Section 50567-7

When using this product - Keep out of eyes. If contact occurs, rinse with water.

  • Discontinue use if irritation or redness occurs.
Section 51727-6

Inactive Ingredients:

Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Glycerin , Aloe Barbadensis Leaf Juice , Bis(Cyano Butylacetate) Anthracenediylidene, Disodium EDTA, Sorbitan Oleate, Ubiquinone, Teprenone, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate, Yeast Polysaccharides, Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Laminaria Digitata Extract, Artemisia Vulgaris Extract, Echinacea Purpurea Extract, Centella Asiatica Extract , Cyclopentasiloxane, Cyclohexasiloxane, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Triethanolamine , PEG-8, Tocopherol , Ascorbyl Palmitate , Ascorbic Acid , Citric Acid, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Arctostaphylos Uva Ursi Leaf Extract , Mitracarpus Scaber Extract, Plankton Extract , Lecithin , Micrococcus Lysate, Arabidopsis Thaliana Extract , Polygonum Aviculare Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin , Hexylene Glycol, Potassium Sorbate, Sodium Benzoate , Sodium Metabisulfite, Sodium Lactate, Biotin, Xanthan Gum, Benzoic Acid, Fragrance (or) Parfum, Benzyl Alcohol, Benzyl Salicylate, Geraniol, Linalool, Eugenol

Section 51945-4

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients:

Octinoxate - 7.5%

Oxybenzone - 6.0%

Octisalate - 5.0%

Avobenzone - 2.0%

Octocrylene - 1.5%

Structured Label Content

Indications and Usage (34067-9)

Uses - This product is suited for broad spectrum UV Protection.

Dosage and Administration (34068-7)

Directions - Apply using fingertips 20-30 minutes before sun exposure. Gentely massage into face and neck. Reapply as needed. Discontinue use if irritation develops.

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 severe skin irritation develops.

Section 50567-7 (50567-7)

When using this product - Keep out of eyes. If contact occurs, rinse with water.

  • Discontinue use if irritation or redness occurs.
Section 51727-6 (51727-6)

Inactive Ingredients:

Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Glycerin , Aloe Barbadensis Leaf Juice , Bis(Cyano Butylacetate) Anthracenediylidene, Disodium EDTA, Sorbitan Oleate, Ubiquinone, Teprenone, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate, Yeast Polysaccharides, Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Laminaria Digitata Extract, Artemisia Vulgaris Extract, Echinacea Purpurea Extract, Centella Asiatica Extract , Cyclopentasiloxane, Cyclohexasiloxane, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Triethanolamine , PEG-8, Tocopherol , Ascorbyl Palmitate , Ascorbic Acid , Citric Acid, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Arctostaphylos Uva Ursi Leaf Extract , Mitracarpus Scaber Extract, Plankton Extract , Lecithin , Micrococcus Lysate, Arabidopsis Thaliana Extract , Polygonum Aviculare Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin , Hexylene Glycol, Potassium Sorbate, Sodium Benzoate , Sodium Metabisulfite, Sodium Lactate, Biotin, Xanthan Gum, Benzoic Acid, Fragrance (or) Parfum, Benzyl Alcohol, Benzyl Salicylate, Geraniol, Linalool, Eugenol

Section 51945-4 (51945-4)

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Octinoxate - 7.5%

Oxybenzone - 6.0%

Octisalate - 5.0%

Avobenzone - 2.0%

Octocrylene - 1.5%

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.154690 · Updated: 2026-03-14T23:05:33.999008