Simpli Day: All-in-one Smartcream Spf-42

Simpli Day: All-in-one Smartcream Spf-42
SPL v2
SPL
SPL Set ID e5aab0ec-eda2-4073-998a-966202dc2233
Route
TOPICAL
Published
Effective Date 2022-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (50 mg) Octisalate (40 mg) Octocrylene Ensulizole
Inactive Ingredients
Aloe Vera Leaf Water Ascorbyl Palmitate Bakuchiol Green Tea Leaf Medium-chain Triglycerides Ceramide Ng Cetostearyl Alcohol Watermelon Cucumber Cyclomethicone 5 Cyclomethicone 4 Dimethicone Ethylhexyl Palmitate Ethylhexylglycerin Ferulic Acid Glycerin Glyceryl Monostearate Hyaluronic Acid Laminaria Digitata Niacinamide Palmitoyl Lysyldioxymethionyllysine Panthenol Phenoxyethanol Polysorbate 20 Stearic Acid Tocopherol Tridecyl Salicylate Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-20
Description

Zinc Oxide 5% Octisalate 5% Octocrylene 5% Ensulizole 4%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 5% Octisalate 5% Octocrylene 5% Ensulizole 4%

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 each morning 15 minutes before sun exposure.
  • During sun exposure, reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying 
  • at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor
Drug Facts

Do Not Use 
  • on damaged or broken skin
Other Information
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Zinc Oxide 5%

Octisalate 5%

Octocrylene 5%

Ensulizole 4%

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Bakuchiol, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ceramide NG, Cetearyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Ferulic Acid, I-Glutathione, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydroxypropyl Cyclodextrin, Lamanaria Digitata (Sea Kelp) Extract, Lecithin, Niacinamide, Palmitoyl Tripeptide-38, Panthenol (Vitamin B5), Phenoxyethanol, Plankton Extract, Polyhydroxystearic Acid, Polypodium Leucotomos Extract, Polysorbate-20, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Zemea (Corn) Propanediol

Questions Or Comments?

Visit www.simpliskinmd.com

Stop Use and Ask Doctor
  • if rash or irritation occurs
When Using This Product 

keep out of eyes. Rinse with water to remove.

Keep Out of Each 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 each morning 15 minutes before sun exposure.
  • During sun exposure, reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying 
  • at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor
Drug Facts

Do Not Use  (Do not use )
  • on damaged or broken skin
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Zinc Oxide 5%

Octisalate 5%

Octocrylene 5%

Ensulizole 4%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Bakuchiol, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ceramide NG, Cetearyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Ferulic Acid, I-Glutathione, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydroxypropyl Cyclodextrin, Lamanaria Digitata (Sea Kelp) Extract, Lecithin, Niacinamide, Palmitoyl Tripeptide-38, Panthenol (Vitamin B5), Phenoxyethanol, Plankton Extract, Polyhydroxystearic Acid, Polypodium Leucotomos Extract, Polysorbate-20, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Zemea (Corn) Propanediol

Questions Or Comments? (Questions or comments?)

Visit www.simpliskinmd.com

Stop Use and Ask Doctor (Stop use and ask doctor)
  • if rash or irritation occurs
When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove.

Keep Out of Each of Children. (Keep out of each of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.675933 · Updated: 2026-03-14T23:01:49.492831