(re)setting Refreshing Mist Spf 40

(re)setting Refreshing Mist Spf 40
SPL v3
SPL
SPL Set ID d4d8f28d-cb00-298d-e053-2995a90a10eb
Route
TOPICAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-05
Description

Active ingredients Purpose 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
  • 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 your 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.

Description

Active ingredients Purpose 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 product is swallowed, get medical help or contact a poison Control Center right away

Section 51727-6

Inactive ingredients:

Alcohol Denat., Bisabolol, Brassica Camprestris/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, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Section 51945-4

Supergoop!

(Re) Setting Refreshing Mist

SPF 40

Broad Spectrum

Sunscreen SPF 40 PA+++

Water & 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

Active ingredients Purpose

Avobenzone 2.9% Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if 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 your 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.

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:

Alcohol Denat., Bisabolol, Brassica Camprestris/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, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Section 51945-4 (51945-4)

Supergoop!

(Re) Setting Refreshing Mist

SPF 40

Broad Spectrum

Sunscreen SPF 40 PA+++

Water & 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)

Active ingredients Purpose

Avobenzone 2.9% Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.439670 · Updated: 2026-03-14T23:05:33.999008