Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 86686617-9c92-4b99-bdf9-b7745e2e850e
Route
TOPICAL
Published
Effective Date 2017-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (6 g) Octisalate (5 g)
Inactive Ingredients
Water Butyloctyl Salicylate Dipropylene Glycol Methyl Trimethicone Biosaccharide Gum-4 Caprylyl Trimethicone Propanediol Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Betaine Ammonium Acryloyldimethyltaurate/vp Copolymer Phenoxyethanol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Dibutyl Lauroyl Glutamide Citrus Aurantium Fruit Oil Carbomer 940 .alpha.-tocopherol Acetate Aminomethyl Propanediol Butylene Glycol Hippophae Rhamnoides Fruit Pentylene Glycol Citrus Bioflavonoids Potassium Sorbate Hydroxyphenyl Propamidobenzoic Acid Brassica Oleracea Var. Botrytis Whole Ethylhexylglycerin Camellia Sinensis Flower Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-05-09

Description

Avobenzone 3% Homosalate 6% Octisalate 5%


Medication Information

Description

Avobenzone 3% Homosalate 6% Octisalate 5%

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

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.

Stop use and ask a docor if rash occurs

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

Directions

• apply generously 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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Inactive Ingredients

Water, Butyloctyl Salicylate, Dipropylene Glycol, Methyl Trimethicone,

Biosaccharide Gum-4, Caprylyl Methicone, Propanediol, Bis-Ethylhexyl

Hydroxydimethoxy Benzylmalonate, Betaine, Acrylates Copolymer,

Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone,

Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Dibutyl

Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Citrus Aurantium

Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Carbomer, Tocopheryl

Acetate, Aminomethyl Propanol, Butylene Glycol, Hippophae Rhamnoides

Fruit Extract, Disodium EDTA, Pentylene Glycol, Aloe Barbadensis Leaf

Extract, Silica, Bioflavonoids, Potassium Sorbate, Hydroxyphenyl

Propamidobenzoic Acid, Brassica Oleracea Italica (Broccoli) Extract,

Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate.

Questions Or Comments?

visit www.glossier.com or call toll-free

1-844-OK-GTEAM 1-844-654-8326

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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

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.

Stop use and ask a docor if rash occurs

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

Directions

• apply generously 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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Dipropylene Glycol, Methyl Trimethicone,

Biosaccharide Gum-4, Caprylyl Methicone, Propanediol, Bis-Ethylhexyl

Hydroxydimethoxy Benzylmalonate, Betaine, Acrylates Copolymer,

Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone,

Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Dibutyl

Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Citrus Aurantium

Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Carbomer, Tocopheryl

Acetate, Aminomethyl Propanol, Butylene Glycol, Hippophae Rhamnoides

Fruit Extract, Disodium EDTA, Pentylene Glycol, Aloe Barbadensis Leaf

Extract, Silica, Bioflavonoids, Potassium Sorbate, Hydroxyphenyl

Propamidobenzoic Acid, Brassica Oleracea Italica (Broccoli) Extract,

Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate.

Questions Or Comments? (Questions or Comments?)

visit www.glossier.com or call toll-free

1-844-OK-GTEAM 1-844-654-8326

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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