Spf 50 Facescreen

Spf 50 Facescreen
SPL v1
SPL
SPL Set ID c2bcc305-4c68-4cf2-8bd1-ea1dd5ba1fef
Route
TOPICAL
Published
Effective Date 2012-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 mL) Homosalate (10 mL) Octinoxate (7.0 mL) Octisalate (5.0 mL) Octocrylene (6.0 mL) Oxybenzone
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Mpa.s) Aloe Vera Leaf Angelica Sinensis Root Ascorbyl Palmitate Butylene Glycol Centella Asiatica Chamomile Chlorphenesin Edetate Disodium Glycerin Asian Ginseng Phenoxyethanol Vitamin A Palmitate Rhus Glabra Bark Steareth-2 Steareth-21 Alpha-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-23

Description

Active ingredients            Purpose Avobenzone 3.0%            Sunscreen Homosalate 10%              Sunscreen Octinoxate 7.0%               Sunscreen Octisalate 5.0%                Sunscreen Octocrylene 5.0%             Sunscreen Oxybenzone 6.0%             Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on broken or damaged 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 a 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 Octocrylene 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, Chamomile Recutita  (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (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

SPF 50 FaceScreen

Broad Spectrum SPF 50 Sunscreen

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

Octocrylene 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 a 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 broken or damaged 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, Chamomile Recutita  (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (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

SPF 50 FaceScreen

Broad Spectrum SPF 50 Sunscreen

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

Octocrylene 5.0%             Sunscreen

Oxybenzone 6.0%             Sunscreen


Advanced Ingredient Data


Raw Label Data

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