FDA.reportPublic FDA data

Dynamic Resurfacing

Manufacturer
ELEMIS Limited
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:17:30

Label at a glance#

ProductDynamic Resurfacing SPF 30
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure and as needed 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 ageing. 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...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.0% }
Octinoxate 1.0% }
Octocrylene 0.5% }

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product,

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure and as needed
  • 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 ageing. 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

Questions?

OTC - QUESTIONS SECTION

US T: 1-855-235-3647

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTI-AGEING

ELEMIS

DYNAMIC RESURFACING

DAY CREAM SPF 30

Skin smoothing day cream

Broad Spectrum SPF 30 | Sunscreen

  • For uneven, dull skin
  • Tri – Enzymes, Poria Cocos, Raspberry Seed oil
  • Renews, smoothes, hydrates

50 ml e 1.6 US fl.oz.

PRINCIPAL DISPLAY PANEL - 50 ml Jar CartonPRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65912-002-502021-08-13C16284748780-1ba0f9c33-230c-a910-e053-dadaa90a0b85Dynamic Resurfacing SPF 30
65912-002-512021-08-13C16284748780-1ba0f9c33-230c-a910-e053-dadaa90a0b85Dynamic Resurfacing SPF 30
65912-002-502021-01-29C16284748780-1ba0f9c33-230c-a910-e053-dadaa90a0b85Dynamic Resurfacing SPF 30
65912-002-512021-01-29C16284748780-1ba0f9c33-230c-a910-e053-dadaa90a0b85Dynamic Resurfacing SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65912-002-50Dynamic ResurfacingSPF 301 in 1 CARTONCREAM17
65912-002-50Dynamic ResurfacingSPF 3050 g in 1 JARCREAM507
65912-002-51Dynamic ResurfacingSPF 3050 g in 1 JARCREAM507
65912-002-52Dynamic ResurfacingSPF 3050 g in 1 JARCREAM507

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65912-00265912-002-50, 65912-002-51, 65912-002-52

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
RASPBERRY SEED OIL9S8867952AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHLORPHENESINI670DAL4SZIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
DOCOSANOL9G1OE216XYIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
XANTHAN GUMTTV12P4NEEIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
PAPAINA236A06Y32IACT
BORAGE SEED OILF8XAG1755SIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EUPHRASIA STRICTAC9642I91WLIACT
MIMOSA TENUIFLORA BARK515MQE449IIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CODIUM TOMENTOSUMB8B45BRU87IACT
ECKLONIA CAVAUXX2N5V39PIACT
GELIDIUM CARTILAGINEUM37LBZ0E1UEIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
SARGASSUM FUSIFORMEX436TJ4A11IACT
MYRTUS COMMUNIS LEAFU20N87188FIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUBTILISIN0ZP13EBC5YIACT
FU LINGXH37TWY5O4IACT

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
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
ndc (package): 65912-002-50
ndc (package): 65912-002-52
ndc (package): 65912-002-51
ndc (product): 65912-002
ndc11 (package): 65912000252
ndc11 (package): 65912000250
ndc11 (package): 65912000251
spl id: 43f4d0f6-557f-a0d7-e063-6394a90a11da
spl set id: fc64720c-060c-4f33-8c76-96456fac270d

Reported adverse events (FAERS/openFDA)#

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