FDA.reportPublic FDA data

EB-5 Super Hydrating Anti-Aging SPF-50

Manufacturer
LIFE O, INC.
Effective date
2024-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:46

Label at a glance#

ProductEB-5 Super Hydrating Anti-Aging SPF-50
Active ingredientOCTOCRYLENE, ZINC OXIDE, OCTISALATE
Label structure7 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun 

Dosage and administration

Apply liberally all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body. Children under 6 months of age: ask a doctor. Use a water -resistant sunscreen if swimming or sweating Sun Protection Measures Sp ending time i...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10.00%

Zinc Oxide 8.00%

Octisalate 5.00%  

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun 

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 a doctor

OTC - STOP USE SECTION

if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body.
  • Children under 6 months of age: ask a doctor.
  • Use a water -resistant sunscreen if swimming or sweating

Sun Protection Measures

Sp ending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Other Information:

OTHER SAFETY INFORMATION

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

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acetyl Hexapeptide-8, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin C), Butylene Glycol, Butyrispermum Parkii (Shea) Butter, C13-16 Isoalkane, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglycerin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Coco Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ethylhexlyglycerin, Ethyl Vanillin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfloer) Oil, Heptyl Undecylenate, Hyaluronic Acid, Magnesium Aluminum Silicate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium citrate, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-5050 mL in 1 TUBECREAM503
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-501 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84060-439EB-5 SUPER HYDRATING ANTI-AGING SPF-50 (OCTOCRYLENE, ZINC OXIDE, OCTISALATE) CREAM [LIFE O, INC.]3Current NDC, 2 package rows20240618_b9521112-d119-4d48-8504-4e46b434f76f.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84060-43984060-439-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYL HEXAPEPTIDE-8 AMIDEL4EL31FWILIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C13-16 ISOPARAFFINLED42LZG6OIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT3RT3536DHYIACT
CARROTL56Z1JK48BIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
HYALURONIC ACIDS270N0TRQYIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
AVOCADO OIL6VNO72PFC1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
EB-5 Super Hydrating Anti-Aging SPF-50OCTOCRYLENE, ZINC OXIDE, OCTISALATELIFE O, INC.b9521112-d119-4d48-8504-4e46b434f76f2024-06-17WarningsExact identifier
ndc (package): 84060-439-00
ndc (product): 84060-439
ndc11 (package): 84060043900
spl id: 1b1351b4-4425-3bb5-e063-6394a90a683f
spl set id: b9521112-d119-4d48-8504-4e46b434f76f

Reported adverse events (FAERS/openFDA)#

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