Glowscreen Spf 40 Sunset

Glowscreen Spf 40 Sunset
SPL v2
SPL
SPL Set ID f7e493da-8fc6-191d-e053-6294a90aa483
Route
TOPICAL
Published
Effective Date 2023-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (8 g) Homosalate (4 g) Avobenzone (3 g)
Inactive Ingredients
1,2-hexanediol Butyloctyl Salicylate Propanediol Lauryl Lactate Glyceryl Monostearate Cetyl Phosphate Hydroxyacetophenone Ferulic Acid Alkyl (c12-15) Benzoate Isododecane Medium-chain Triglycerides Coco-caprylate Isodecyl Neopentanoate Arachidyl Alcohol Docosanol Limonium Platyphyllum Whole Arachidyl Glucoside Leuconostoc/radish Root Ferment Filtrate Cocoa Sunflower Oil Arginine Polymethylsilsesquioxane (4.5 Microns) Titanium Dioxide Butylene Glycol Triethoxycaprylylsilane Pantothenic Acid Tocopherol Caprylyl Glycol Omega-3 Fatty Acids Hyaluronate Sodium Ethylhexyl Hydroxystearate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Sodium Stearoyl Glutamate Brown Iron Oxide Water O-18 Glycerin Glyceryl Stearate Citrate Diisopropyl Sebacate Mica Niacinamide Trisodium Ethylenediamine Disuccinate Bismuth Cation Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%


Medication Information

Warnings and Precautions

For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs • 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 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 • Children under 6 months: Ask a doctor

Description

Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%

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 44425-7

Protect the product in this container from excessive heat and direct sun

Section 50565-1

• Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

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

Section 51945-4

Supergoop!

Glow Screen SPF 40

Sunset

1.7 fl. oz./ 50 mL

Active Ingredients:

Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%


Structured Label Content

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

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 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 • Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs • When using this product keep out of eyes • Rinse with water to remove

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat and direct sun

Section 50565-1 (50565-1)

• Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Supergoop!

Glow Screen SPF 40

Sunset

1.7 fl. oz./ 50 mL

Active Ingredients:

Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%


Advanced Ingredient Data


Raw Label Data

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