Spf 50 Moisturizing Sunscreen

Spf 50 Moisturizing Sunscreen
SPL v3
SPL
SPL Set ID 48013b2c-d398-42fc-ab1d-b628d1a3993d
Route
TOPICAL
Published
Effective Date 2018-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6 g) Zinc Oxide (12 g)
Inactive Ingredients
Water Polysorbate 60 Coconut Alkanes Alkyl (c12-15) Benzoate Octyldodecyl Neopentanoate Cetostearyl Alcohol Glycerin Cyclomethicone 5 Glyceryl Monostearate Peg-100 Stearate Levomenol Arabica Coffee Oil Pentylene Glycol Tetrahexyldecyl Ascorbate Lutein Ascorbyl Palmitate Tocopherol .beta.-carotene Coco-caprylate/caprate Folic Acid Safflower Oil Tomato Seed Oil .alpha.-tocopherol Acetate Bilberry Argan Oil Dimethicone Dibasic Potassium Phosphate Hydrogenated Soybean Lecithin Potassium Phosphate, Monobasic Corn Oil Polyhydroxystearic Acid (2300 Mw) Alcohol Butylene Glycol Xanthan Gum Edetate Disodium Citric Acid Monohydrate Dehydroacetic Acid Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-04
Description

Active Ingredients                            Purpose Octinoxate 6%, Zinc Oxide 12%       Sunscreen

Medication Information

Warnings and Precautions

Warnings

For External Use Only

Do not use on damaged or broken skin

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

• Apply liberally 15 minutes before sun exposure

• Reapplyat 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 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10a.m. – 2p.m.

• Wear long-sleeve shirts, pants, hats, and sunglasses

• Children under six months consult a physician

Description

Active Ingredients                            Purpose Octinoxate 6%, Zinc Oxide 12%       Sunscreen

Section 50565-1

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

Section 51727-6

Inactive ingredients   ​ ​Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol

Section 51945-4

SPF 50+

Moisturizing Sunscreen

Broad Spectrum Daily Use

1Fl Oz/30 mL

Section 55105-1

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.

Section 55106-9

Active Ingredients                            Purpose

Octinoxate 6%, Zinc Oxide 12%       Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

• Apply liberally 15 minutes before sun exposure

• Reapplyat 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 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10a.m. – 2p.m.

• Wear long-sleeve shirts, pants, hats, and sunglasses

• Children under six months consult a physician

Warnings and Precautions (34071-1)

Warnings

For External Use Only

Do not use on damaged or broken skin

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients   ​ ​Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol

Section 51945-4 (51945-4)

SPF 50+

Moisturizing Sunscreen

Broad Spectrum Daily Use

1Fl Oz/30 mL

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

Active Ingredients                            Purpose

Octinoxate 6%, Zinc Oxide 12%       Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:24.610922 · Updated: 2026-03-14T23:00:48.264963