Spf 50 Facescreen

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 g) Homosalate (10 g) Octinoxate (7 g) Octisalate (5 g) Octocrylene (6 g) Oxybenzone

Inactive Ingredients

Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Angelica Sinensis Root Ascorbyl Palmitate 1,3-butylene Glycol Centella Asiatica Cetyl Dimethicone 25 Chamomile Chlorphenesin Edetate Disodium Glycerin Nasturtium Officinale Asian Ginseng Phenoxyethanol Egg Phospholipids Vitamin A Palmitate Rhus Glabra Bark Steareth-2 Steareth-21 .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-07-11

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

· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· 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 Avobenzone 3.0% Sunscreen Homosalate 10% Sunscreen Octinoxate 7.0% Sunscreen Octisalate 5.0% Sunscreen Oxybenzone 6.0% 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

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)

Section 51945-4

Bioelements

Used in Professional Facials

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunscreen

Daily antioxidant moisturizer

Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

68 mL/ 2.3 Fl. Oz.

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

Avobenzone 3.0% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.0% Sunscreen

Octisalate 5.0% Sunscreen

Oxybenzone 6.0% 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

· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· 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)

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)

Section 51945-4 (51945-4)

Bioelements

Used in Professional Facials

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunscreen

Daily antioxidant moisturizer

Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

68 mL/ 2.3 Fl. Oz.

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

Avobenzone 3.0% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.0% Sunscreen

Octisalate 5.0% Sunscreen

Oxybenzone 6.0% Sunscreen

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Stop use and ask a doctor if rash occurs", "34068-7": "Directions · Apply liberally 15 minutes before sun exposure · Use a water resistant sunscreen if swimming or sweating · Reapply at least every 2 hours · 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", "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.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)", "51945-4": "Bioelements Used in Professional Facials SPF 50 FaceScreen Broad Spectrum SPF 50 Sunscreen Daily antioxidant moisturizer Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed 68 mL/ 2.3 Fl. Oz.", "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", "55106-9": "Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 10% Sunscreen Octinoxate 7.0% Sunscreen Octisalate 5.0% Sunscreen Oxybenzone 6.0% Sunscreen"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information