Rodial Broad Spectrum Spf 50 Drops Anti-blue Light & Pollution

Rodial Broad Spectrum Spf 50 Drops Anti-blue Light & Pollution
SPL v2
SPL
SPL Set ID d1c69335-70c7-47e7-8267-ed95900cb843
Route
TOPICAL
Published
Effective Date 2021-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Octinoxate (75 mg) Oxybenzone (60 mg) Octisalate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Butylene Glycol Alkyl (c12-15) Benzoate Glyceryl Monostearate Glycerin Peg-100 Stearate Octyldodecanol Glyceryl Stearate Se Propanediol Phenoxyethanol Helianthus Annuus Seed Wax Saccharide Isomerate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Sodium Stearoyl Glutamate .alpha.-tocopherol Acetate Benzyl Alcohol Levomenol Echium Plantagineum Seed Oil 1,2-hexanediol Carbomer Homopolymer, Unspecified Type Edetate Disodium Anhydrous Hyaluronate Sodium Acacia Decurrens Flower Polyglycerin-3 Helianthus Annuus Flowering Top Sodium Hydroxide Biosaccharide Gum-4 Dehydroacetic Acid Ethylbisiminomethylguaiacol Manganese Chloride Cardiospermum Halicacabum Flowering Top Citric Acid Monohydrate Sodium Citrate Limonene, (+)- Isomethyl-.alpha.-ionone Tocopherol .beta.-citronellol, (r)- Jojoba Oil Buddleja Officinalis Flower Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-20

Description

Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • 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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
Do Not Use

on damaged or broken skin

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%







Inactive Ingredients

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, PEG -100 Stearate, Octyldodecanol, Jojoba Esters, Glyceryl Stearate SE, Propanediol, Phenoxyethanol, Helianthus Annuus (Sunflower) Seed Wax, Saccharide Isomerate, Methyl Methacrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Bisabolol, Echium Plantagineum Seed Oil, Lecithin, Buddleja Officinalis Flower Extract, 1,2-Hexanediol, Carbomer, Disodium EDTA, Sodium Hyaluronate, Acacia Decurrens Flower Extract, Polyglycerin-3, Parfum (Fragrance), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hydroxide, Biosaccharide Gum-4, Dehydroacetic Acid, Ethylbisiminomethylguaiacol Manganese Chloride, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Sodium Citrate, Limonene, Alpha-isomethyl Ionone, Tocopherol, Citronellol.

Questions Or Comments?
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help, or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • 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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%







Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, PEG -100 Stearate, Octyldodecanol, Jojoba Esters, Glyceryl Stearate SE, Propanediol, Phenoxyethanol, Helianthus Annuus (Sunflower) Seed Wax, Saccharide Isomerate, Methyl Methacrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Bisabolol, Echium Plantagineum Seed Oil, Lecithin, Buddleja Officinalis Flower Extract, 1,2-Hexanediol, Carbomer, Disodium EDTA, Sodium Hyaluronate, Acacia Decurrens Flower Extract, Polyglycerin-3, Parfum (Fragrance), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hydroxide, Biosaccharide Gum-4, Dehydroacetic Acid, Ethylbisiminomethylguaiacol Manganese Chloride, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Sodium Citrate, Limonene, Alpha-isomethyl Ionone, Tocopherol, Citronellol.

Questions Or Comments? (Questions or comments?)
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help, or contact a Poison Control Center right away.


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Raw Label Data

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