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
Purpose

Sunscreen

Description

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

Medication Information

Warnings
  • For external use only
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

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

Description

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

Drug Facts

Do Not Use 
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Zinc Oxide 5%

Octisalate 5%

Octocrylene 5%

Ensulizole 4%

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

Warnings
  • For external use only
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

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

Drug Facts

Do Not Use  (Do not use )
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Zinc Oxide 5%

Octisalate 5%

Octocrylene 5%

Ensulizole 4%

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