FDA.reportPublic FDA data

Bio Active Complex SPF 15

Manufacturer
ALLURE LABS INC
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:34

Label at a glance#

ProductBio Active Complex SPF 15
Active ingredientZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide - 18.9%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 minutes prior to sun exposure.
  • Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in sun sun, especially from 10 am - 2 pm.
  • wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Water, Caprilic/Capric Triglyceride, Polyglyceryl-2 Sesquiisostearate, Cetyl Octanoate, Cera Alba Beeswax, Sodium Hyaluronate, Caprylyl Glycol, Hexylene Glycol, Yeast Extract, Biosaccharide Gum-1, Camellia Sinensis Leaf Extract, Butyrospermum Parkii (Shea butter/Vit. A,E,F), Malus Domestica Fruit Cell Culture, Xanthan Gum, Glycerin, Lecithin, Xanthan Gum, Magnesium Sulfate, Tocopheryl Acetate, Allantoin, Magnesium Stearate, Aluminum Stearate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Phenoxyethanol, Ethylhexylglycerin, Copemicia Cerifera Wax, Oenothera Biennis Oil, Resorcinol.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Call toll free 1-800 830-1491 in the USA.

info@atzen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Toll free in USA: 800.830.1491

Email: info@atzen.com

www.atzen.com

Developed in France. Made in USA.

Bio Active Complex SPF 15Bio Active Complex SPF 15

Bio Active Complex SPF 15Bio Active Complex SPF 15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62742-4163-22022-01-28C16284748780-1d6a99b39-d030-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4163-1Bio Active Complex SPF 1530 mL in 1 TUBECREAM301
62742-4163-2Bio Active Complex SPF 151 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4163BIO ACTIVE COMPLEX SPF 15 (ZINC OXIDE) CREAM [ALLURE LABS INC]1Legacy NDC, 2 package rows20171220_768db334-2a0a-476d-8239-a517156c663b.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-416362742-4163-1, 62742-4163-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
POLYGLYCERYL-2 SESQUIISOSTEARATELA272Q68GQIACT
CETYL OCTACOSANOATEO7F4812VDXIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-20 SORBITAN STEARATEHD40WR33LCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
YEAST MANNAN91R887N59PIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
SHEA BUTTERK49155WL9YIACT
MALUS DOMESTICA FLOWEREF626V855KIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
TOCOPHERYL NICOTINATE, D-.ALPHA.WI1J5UCY5CIACT
ALLANTOIN344S277G0ZIACT
MAGNESIUM STEARATE70097M6I30IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
COPERNICIA ALBA WHOLE2HXP20S5QUIACT
OENOTHERA BIENNIS76UI55V071IACT
RESORCINOLYUL4LO94HKIACT

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
4c70ad4f-b396-4a94-920a-a75dcf67de8e768db334-2a0a-476d-8239-a517156c663b2017-12-18WarningsExact identifier
spl id: 4c70ad4f-b396-4a94-920a-a75dcf67de8e
spl set id: 768db334-2a0a-476d-8239-a517156c663b

Reported adverse events (FAERS/openFDA)#

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