FDA.reportPublic FDA data

Advanced Day Ultimate Protect Sunscreen SPF 50

Manufacturer
Medik8 Limited
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:51:06

Label at a glance#

ProductAdvanced Day Ultimate Protect Sunscreen SPF 50
Active ingredientETHYLHEXYL SALICYLATE, OCTOCRYLENE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Butyl Methoxydibenzoylmethane 2.8% Sunscreen

Ethylhexyl Salicylate 4.8% ...................... Sunscreen

Homosalate 10%..................................... Sunscreen

Octocrylene 9.5%...................................... Sunscreen

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: ask a doctor
  • 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 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

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Butyloctyl Salicylate, Dibutyl Adipate, Glycerin, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Dimethicone, Isododecane, Glycereth-26, Glyceryl Steareate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, PPG-12/SMDI Copolymer, Silica, Squalane, Sodium Hyaluronate Propylene Glycol Dibenzoate, Polysilicone-11, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Ectoin, Hydroxyacetophenone, Inulin Lauryl Carbamate, Disodium EDTA, Benzoic Acid, Sodium Hydroxide, Spirulina Maxima Extract, Dehydroacetic Acid, Carnosine, Citrus Grandis (Grapefruit) Peel Oil, Phenoxyethanol, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Limon (Lemon) Peel Oil, Lecithin, Pelargonium Graveolens (Geranium) Flower Oil, Limonene, Citronellol, Linalool, Geraniol, Citral

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medik8

Advanced Day Ultimate Protect

Age-Defying Moisturizer

Sunscreen SPF 50+ with photolyase & Ectoin

Broad Spectrum SPF 50+

1.69 FL. OZ. (50 mL)

advanced day Ultimate Protect Sunscreen SPF 50advanced day Ultimate Protect Sunscreen SPF 50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79988-002-05Advanced Day Ultimate Protect Sunscreen SPF 505 mL in 1 BOTTLECREAM51
79988-002-50Advanced Day Ultimate Protect Sunscreen SPF 5050 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79988-002ADVANCED DAY ULTIMATE PROTECT SUNSCREEN SPF 50 (BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE) CREAM [MEDIK8 LIMITED]1Current NDC, 2 package rows20250109_29071920-ba90-871a-e063-6294a90aee27.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79988-00279988-002-50, 79988-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEHYDROACETIC ACID2KAG279R6RIACT
BERGAMOT OIL39W1PKE3JIIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CITRONELLOLP01OUT964KIACT
ETHYLHEXYL SALICYLATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SQUALANEGW89575KF9IACT
CARNOSINE8HO6PVN24WIACT
SILICAETJ7Z6XBU4IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
GLYCERINPDC6A3C0OXIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
ISODODECANEA8289P68Y2IACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
HOMOSALATEV06SV4M95SACTIB
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
DIMETHICONE 20H8YMB5QY0DIACT
BUTYL METHOXYDIBENZOYLMETHANEG63QQF2NOXACTIB
DIBUTYL ADIPATEF4K100DXP3IACT
PROPYLENE GLYCOL DIBENZOATEEQY32Z1AN4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
LINALOOLD81QY6I88EIACT
CITRUS LIMON (LEMON) PEEL OILI9GRO824LLIACT
SODIUM HYALURONATEYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
GERANIOLL837108USYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SPIRULINA MAXIMA9K7IG15M0QIACT
GLYCERETH-26NNE56F2N14IACT
ECTOINE7GXZ3858RYIACT

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
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
ndc (package): 79988-002-05
ndc (package): 79988-002-50
ndc (product): 79988-002
ndc11 (package): 79988000250
ndc11 (package): 79988000205
spl id: 29071920-ba91-871a-e063-6294a90aee27
spl set id: 29071920-ba90-871a-e063-6294a90aee27

Reported adverse events (FAERS/openFDA)#

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