Skin Defense Concealer Broad Spectrum Spf 15

Skin Defense Concealer Broad Spectrum Spf 15
SPL v2
SPL
SPL Set ID b5ba9632-f3a0-4086-b3d7-dde56fa918d0
Route
TOPICAL
Published
Effective Date 2019-06-11
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 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 NOT FINAL Active Since 2013-05-22

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 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

   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

Skin Defense Concealer Broad Spectrum SPF 15

15 ml .5 Fl Oz (US)

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 doctor if 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 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/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)

Skin Defense Concealer Broad Spectrum SPF 15

15 ml .5 Fl Oz (US)

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

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