Defense Refresh (re)setting Mist Spf 40

Defense Refresh (re)setting Mist Spf 40
SPL v4
SPL
SPL Set ID b95ad8e3-978b-b721-e053-2a95a90a1e54
Route
TOPICAL
Published
Effective Date 2021-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.8 g) Avobenzone (2.9 g) Octisalate (4.9 g) Octocrylene (9.5 g)
Inactive Ingredients
Alcohol Butyloctyl Salicylate Dicaprylyl Carbonate Diethylhexyl Syringylidenemalonate Diheptyl Succinate Ethyl Ferulate Isododecane Peppermint Oil Spearmint Oil Rosemary Oil Nylon-12 Povidone, Unspecified Levomenol Medium-chain Triglycerides Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Lauroyl Lysine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-20

Description

Avobenzone 2.9%..............Sunscreen Homosalate 9.8%.............Sunscreen Octisalate 4.9%..................Sunscreen Octocrylene 9.5%...............Sunscreen


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 if rash occurs.

Dosage and Administration

· Shake well then 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 2.9%..............Sunscreen Homosalate 9.8%.............Sunscreen Octisalate 4.9%..................Sunscreen Octocrylene 9.5%...............Sunscreen

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

Alcohol Denat., Bisabolol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Section 51945-4

Supergoop!

Defense Refresh

(RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SFP 40

Water & Sweat Resistant (40 minutes)

1.0 fl. oz. / 30 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 2.9%..............Sunscreen

Homosalate 9.8%.............Sunscreen

Octisalate 4.9%..................Sunscreen

Octocrylene 9.5%...............Sunscreen

Section 60561-8

Protect the product in this contianer from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

· Shake well then 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 swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Alcohol Denat., Bisabolol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Section 51945-4 (51945-4)

Supergoop!

Defense Refresh

(RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SFP 40

Water & Sweat Resistant (40 minutes)

1.0 fl. oz. / 30 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 2.9%..............Sunscreen

Homosalate 9.8%.............Sunscreen

Octisalate 4.9%..................Sunscreen

Octocrylene 9.5%...............Sunscreen

Section 60561-8 (60561-8)

Protect the product in this contianer from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)