Glow Screen Spf 40

Glow Screen Spf 40
SPL v7
SPL
SPL Set ID 21569637-332a-461b-bf6c-33af6a83a155
Route
TOPICAL
Published
Effective Date 2020-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Octocrylene (10 g)
Inactive Ingredients
Water Propanediol Butyloctyl Salicylate Glycerin Alkyl (c12-15) Benzoate Polymethylsilsesquioxane (4.5 Microns) Niacinamide Glyceryl Stearate Citrate Bismuth Oxychloride Mica Titanium Dioxide Lauryl Lactate Isododecane Isodecyl Neopentanoate Glyceryl Monostearate Diisopropyl Sebacate Cetyl Phosphate Medium-chain Triglycerides Coco-caprylate Ethylhexyl Hydroxystearate Butylene Glycol Arginine Hydroxyacetophenone Caprylyl Glycol 1,2-hexanediol Ferric Oxide Red Hyaluronate Sodium Chlorphenesin Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trisodium Ethylenediamine Disuccinate Lecithin, Soybean Limonium Gerberi Whole Leuconostoc/radish Root Ferment Filtrate Cocoa Pantothenic Acid Tocopherol Sunflower Oil Ferulic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Active Ingredients  Purpose Avobenzone      3% Sunscreen Octisalate         5% Sunscreen Octocylene        10% 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 generously and evenly 15 minutes before sun exposure
  •   Reapply at least every 2 hours

 Use a water resistant sunscreen if swimming or sweating

 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 value 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
  •  Children under 6 months: Ask a doctor
Description

Active Ingredients  Purpose Avobenzone      3% Sunscreen Octisalate         5% Sunscreen Octocylene        10% 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, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

Section 51945-4

Supergoop!

Glowscreen

SPF 40 Sunrise

Broad Spectrum Sunscreen

SPF 40 PA+++

1.7 fl. oz./ 50 ml.

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% Sunscreen

Octisalate         5% Sunscreen

Octocylene        10% 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 generously and evenly 15 minutes before sun exposure
  •   Reapply at least every 2 hours

 Use a water resistant sunscreen if swimming or sweating

 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 value 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
  •  Children under 6 months: Ask a doctor
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, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

Section 51945-4 (51945-4)

Supergoop!

Glowscreen

SPF 40 Sunrise

Broad Spectrum Sunscreen

SPF 40 PA+++

1.7 fl. oz./ 50 ml.

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% Sunscreen

Octisalate         5% Sunscreen

Octocylene        10% Sunscreen


Advanced Ingredient Data


Raw Label Data

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