Daily Dose Vitamin C And Broad Spectrum Spf 40 Serum

Daily Dose Vitamin C And Broad Spectrum Spf 40 Serum
SPL v7
SPL
SPL Set ID aed0dd03-1695-a5a9-e053-2995a90acfdc
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Octisalate (5 g) Avobenzone (3 g) Octocrylene (6 g)
Inactive Ingredients
Silicon Dioxide Phenethyl Benzoate Polyglyceryl-2 Isostearate Rosa Centifolia Flower Bellis Perennis Flower Octyldodecyl Citrate Crosspolymer Hyaluronate Sodium Glyceryl Monocaprylate 3-o-ethyl Ascorbic Acid Glycerin Sodium Chloride Citric Acid Monohydrate Kakadu Plum Niacinamide Caprylyl Glycol Pentylene Glycol Propanediol Chlorphenesin Disteardimonium Hectorite Xanthan Gum Ethylhexylglycerin Jasminum Officinale Flower Magnesium Sulfate, Unspecified Form Water C13-15 Alkane Trisodium Ethylenediamine Disuccinate Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-08 Until 2020-11-01

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 9% Sunscreen Octisalate 5% Sunscreen Octocrylene 6% Sunscreen


Medication Information

Warnings and Precautions

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
Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

  • Apply generously and evenly 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 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 3% Sunscreen Homosalate 9% Sunscreen Octisalate 5% Sunscreen Octocrylene 6% 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 Water (Aqua), 3-0-Ethyl Ascorbic Acid, C13-15 Alkane, Glycerin, Polyglyceryl-6 Ricinoleate, Polyglyceryl-6 Polyhydroxystearate, Octyldodecyl Citrate Crosspolymer, Niacinamide, Phenethyl Benzoate, Polyester-25, Silica, Terminalia Ferdinandiana Fruit Extract, Rosa Centifolia Flower Extract, Jasminum Officinale (Jasmine) Flower Extract, Bellis Perennis (Daisy) Flower Extract, Hydrolyzed sodium Hyaluronate, Sodium Hyaluronate, Pseudoalteromonas Ferment Extract, Glyceryl Caprylate, Disteardimonium Hectorite, Xanthan Gum, Polyglyceryl-2 Isostearate, Magnesium Sulfate, Sodium Chloride, Citric Acid, Trisodium Ethylenediamine Dissucinate, Sodium Citrate, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin.

Section 51945-4

Daily Dose Vitamin C + SPF

SPF 40

Broad Spectrum Serum

SPF 40 PA +++

1fl. oz. / 30 ml.

Section 55105-1

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.
Section 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 9% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 6% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly 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 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)

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
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 Water (Aqua), 3-0-Ethyl Ascorbic Acid, C13-15 Alkane, Glycerin, Polyglyceryl-6 Ricinoleate, Polyglyceryl-6 Polyhydroxystearate, Octyldodecyl Citrate Crosspolymer, Niacinamide, Phenethyl Benzoate, Polyester-25, Silica, Terminalia Ferdinandiana Fruit Extract, Rosa Centifolia Flower Extract, Jasminum Officinale (Jasmine) Flower Extract, Bellis Perennis (Daisy) Flower Extract, Hydrolyzed sodium Hyaluronate, Sodium Hyaluronate, Pseudoalteromonas Ferment Extract, Glyceryl Caprylate, Disteardimonium Hectorite, Xanthan Gum, Polyglyceryl-2 Isostearate, Magnesium Sulfate, Sodium Chloride, Citric Acid, Trisodium Ethylenediamine Dissucinate, Sodium Citrate, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin.

Section 51945-4 (51945-4)

Daily Dose Vitamin C + SPF

SPF 40

Broad Spectrum Serum

SPF 40 PA +++

1fl. oz. / 30 ml.

Section 55105-1 (55105-1)

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.
Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 9% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 6% Sunscreen


Advanced Ingredient Data


Raw Label Data

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