Unseen Sunscreen Body Spf 40

Unseen Sunscreen Body Spf 40
SPL v2
SPL
SPL Set ID ec1c30bd-76e1-9d00-e053-2a95a90a1759
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Octocrylene (10 g) Homosalate (9 g)
Inactive Ingredients
Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Caprylyl Trisiloxane Silica Dimethyl Silylate Phenyl Trimethicone Olea Europaea Fruit Volatile Oil Olea Europaea (olive) Oil Unsaponifiables Medium-chain Triglycerides Isododecane Olea Europaea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-28

Description

Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 10%


Medication Information

Warnings and Precautions

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 is rash occurs

Dosage and Administration
  • apply generously and evenly 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: Ask a doctor

Description

Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 10%

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: Isododecane, Dimethicone, Caprylyl Methicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/CapricTriglyceride, Phenyl Trimethicone, Olea Europaea Olive Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Silica Dimethyl Silyate

Section 51945-4

Unseen Sunscreen Body

SPF 40 PA +++

Broad Spectrum Sunscreen

Water and Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 mL

Section 55105-1

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

Avobenzone 3%

Homosalate 9%

Octisalate 5%

Octocrylene 10%


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor is rash occurs

Dosage and Administration (34068-7)
  • apply generously and evenly 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: Ask a doctor

Warnings and Precautions (34071-1)

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: Isododecane, Dimethicone, Caprylyl Methicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/CapricTriglyceride, Phenyl Trimethicone, Olea Europaea Olive Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Silica Dimethyl Silyate

Section 51945-4 (51945-4)

Unseen Sunscreen Body

SPF 40 PA +++

Broad Spectrum Sunscreen

Water and Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 mL

Section 55105-1 (55105-1)

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)

Avobenzone 3%

Homosalate 9%

Octisalate 5%

Octocrylene 10%


Advanced Ingredient Data


Raw Label Data

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