Spf 50 Face Sunscreen

Spf 50 Face Sunscreen
SPL v5
SPL
SPL Set ID 981c7b3c-d7d6-483d-bf32-10d526be5b3f
Route
TOPICAL
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Aminomethylpropanol Angelica Sinensis Root Ascorbyl Palmitate Butylene Glycol Centella Asiatica Cetyl Dimethicone 25 Chamomile Chlorphenesin Edetate Disodium Glycerin Nasturtium Officinale Asian Ginseng Phenoxyethanol Lecithin, Soybean Vitamin A Palmitate Steareth-2 Steareth-21 .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-04

Description

Active Ingredients                 Purpose Avobenozone 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 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Description

Active Ingredients                 Purpose Avobenozone 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 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Aminomethyl Propanol, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Buylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nasturtium Officinale (Watercress) Extract, Panax Ginseng (Genseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Water (Aqua, Eau)

Section 51945-4

Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

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

Avobenozone 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 10a.m. - 2p.m.
  • Wear long-sleeved 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 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Aminomethyl Propanol, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Buylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nasturtium Officinale (Watercress) Extract, Panax Ginseng (Genseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Water (Aqua, Eau)

Section 51945-4 (51945-4)

Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

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

Avobenozone 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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