SIMPLI DAY All In One SmartCream SPF 42

Manufacturer
SIMPLI SKIN MD LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:15

Label at a glance#

ProductSIMPLI DAY All In One SmartCream SPF 42
Active ingredientZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE
Label structure8 sections

Indications and 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

Dosage and administration

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 Protecti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5%

Octisalate 5%

Octocrylene 5%

Ensulizole 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

Do not use 

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product 

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

OTC - STOP USE SECTION

  • if rash or irritation occurs

Keep out of each of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82733-294-00SIMPLI DAY All In One SmartCream SPF 421 in 1 BOXCREAM12
82733-294-00SIMPLI DAY All In One SmartCream SPF 4250 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82733-294SIMPLI DAY ALL IN ONE SMARTCREAM SPF 42 (ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE) CREAM [SIMPLI SKIN MD LLC]2Current NDC, Legacy NDC, 2 package rows20231112_e5aab0ec-eda2-4073-998a-966202dc2233.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82733-29482733-294-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
ndc (package): 82733-294-00
ndc (product): 82733-294
ndc11 (package): 82733029400
spl id: 09e32c60-2b83-0226-e063-6294a90a6a2f
spl set id: e5aab0ec-eda2-4073-998a-966202dc2233

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.