Skin Defense Concealer Spf 15

Skin Defense Concealer Spf 15
SPL v11
SPL
SPL Set ID 3d261d0d-a122-4e5e-86ac-89a19d3e8999
Route
TOPICAL
Published
Effective Date 2013-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7 g) Octisalate (3 g) Oxybenzone (2 g)
Inactive Ingredients
Water Butylene Glycol Glyceryl Monostearate Stearic Acid Isopropyl Isostearate Di-ppg-3 Myristyl Ether Adipate Potassium Cetyl Phosphate Hydrogenated Palm Glycerides Cetyl Alcohol Trolamine Lecithin, Soybean Silicon Dioxide Dimethicone Polysorbate 20 Alfalfa Seed Dmdm Hydantoin Xanthan Gum Chondrus Crispus Magnesium Aluminum Silicate .alpha.-tocopherol Acetate Sweet Potato Peg-4 Laurate Iodopropynyl Butylcarbamate Edetate Trisodium Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-05-22 Until 2019-06-01
Description

Active Ingredients       Purpose Octinoxate 7%                Sunscreen Octisalate 3%                 Sunscreen Oxybenzone 2%             Sunscreen 

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin

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

Indications and Usage

Stop use and ask a doctorif rash occurs

Dosage and Administration

Directions

   Apply liberally 15 minutes before sun exposure

   Reapply at least every 2 hours

   Use a water resistant sunscreen if swimming or sweating

   Children under 6 months: Ask a doctor

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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

Description

Active Ingredients       Purpose Octinoxate 7%                Sunscreen Octisalate 3%                 Sunscreen Oxybenzone 2%             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/Aqua, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]

Section 51945-4

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 7%                Sunscreen

Octisalate 3%                 Sunscreen

Oxybenzone 2%             Sunscreen 

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctorif rash occurs

Dosage and Administration (34068-7)

Directions

   Apply liberally 15 minutes before sun exposure

   Reapply at least every 2 hours

   Use a water resistant sunscreen if swimming or sweating

   Children under 6 months: Ask a doctor

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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin

When using this productkeep 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/Aqua, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]

Section 51945-4 (51945-4)

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 7%                Sunscreen

Octisalate 3%                 Sunscreen

Oxybenzone 2%             Sunscreen 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.595118 · Updated: 2026-03-14T23:02:21.986500