drug facts

drug facts
SPL v1
SPL
SPL Set ID 35e70dcf-a00a-4401-8127-09219931e3ac
Route
topical
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (15 g) octisalate (5 g) octocrylene (10 g)
Inactive Ingredients
alcohol isobutane butyloctyl salicylate diethylhexyl 2,6-naphthalate mica dibutyl adipate .alpha.-tocopherol acetate ascorbyl palmitate mauritia flexuosa fruit oil prunus armeniaca seed helianthus annuus seed wax mimosa tenuiflora bark titanium dioxide brown iron oxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-01-01

Description

Avobenzone 2.1% Homosalate 10.50% Octisalate 3.50% Octocrylene 7.00%


Medication Information

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F. Use only as directed. Intentional

misuse by deliberately con-centrating and inhaling the contents can be

harmful or fatal. Keep out of reach of children.

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.

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

Directions

• apply generously 15 minutes before sun exposure

• reapply: •after 40 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• 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

Inactive Ingredients

Alcohol Denat., Isobutane, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Parfum/Fragrance, Acrylates/Octylacrylamide Copolymer, Mica, Dibutyl Adipate, Tocopheryl Acetate, Ascorbyl Palmitate, Mauritia Flexuosa Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Mimosa Tenuiflora Bark Extract, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).

Description

Avobenzone 2.1% Homosalate 10.50% Octisalate 3.50% Octocrylene 7.00%

Principal Display Panel

Active Ingredients

Avobenzone 2.1%

Homosalate 10.50%

Octisalate 3.50%

Octocrylene 7.00%

Questions Or Comments?

visit Glossier.com, email us at [email protected],

or call toll-free 1-844-654-8326


Structured Label Content

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F. Use only as directed. Intentional

misuse by deliberately con-centrating and inhaling the contents can be

harmful or fatal. Keep out of reach of children.

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.

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

Directions

• apply generously 15 minutes before sun exposure

• reapply: •after 40 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• 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

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Parfum/Fragrance, Acrylates/Octylacrylamide Copolymer, Mica, Dibutyl Adipate, Tocopheryl Acetate, Ascorbyl Palmitate, Mauritia Flexuosa Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Mimosa Tenuiflora Bark Extract, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).

Principal Display Panel

Active Ingredients

Avobenzone 2.1%

Homosalate 10.50%

Octisalate 3.50%

Octocrylene 7.00%

Questions Or Comments? (Questions or Comments?)

visit Glossier.com, email us at [email protected],

or call toll-free 1-844-654-8326


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)