FDA.reportPublic FDA data

SPF 50 Face Sunscreen

Manufacturer
Bioelements, Inc
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:26:31

Label at a glance#

ProductSPF 50 Face Sunscreen Bioelements
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                 Purpose

Avobenozone 3.0% ............. Sunscreen

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

Octinoxate 7.0% ............... Sunscreen

Octisalate 5.0% ................ Sunscreen

Octocrylene 5.0% ............. Sunscreen

Oxybenzone 6.0% ............. 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 product is 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
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Aminomethyl Propanol, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Buylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nasturtium Officinale (Watercress) Extract, Panax Ginseng (Genseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Water (Aqua, Eau)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

68 mL/ 2.3 Fl. Oz.

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-201-022024-08-27C16284748780-11030e365-45af-111a-e063-dadaa90a10e2SPF 50 Face Sunscreen
49825-201-022024-01-30C16284748780-11030e365-45af-111a-e063-dadaa90a10e2SPF 50 Face Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-201-01SPF 50 Face SunscreenBioelements68 mL in 1 TUBECREAM685
49825-201-02SPF 50 Face SunscreenBioelements1 in 1 BOXCREAM15

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49825-20149825-201-01, 49825-201-02
56152-4008

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ANGELICA SINENSIS ROOTB66F4574UGIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CENTELLA ASIATICA7M867G6T1UIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
CHAMOMILEFGL3685T2XIACT
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
NASTURTIUM OFFICINALEYH89GMV676IACT
ASIAN GINSENGCUQ3A77YXIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements, Inc981c7b3c-d7d6-483d-bf32-10d526be5b3f2025-12-17WarningsExact identifier
ndc (package): 49825-201-02
ndc (package): 49825-201-01
ndc (product): 49825-201
ndc11 (package): 49825020101
ndc11 (package): 49825020102
spl id: 462ab8c8-dd89-a7d5-e063-6394a90a6c66
spl set id: 981c7b3c-d7d6-483d-bf32-10d526be5b3f
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd498b16c8-ba54-4a0a-8dbc-4b5cc368e2142025-10-14WarningsExact identifier
ndc (product): 56152-4008

Reported adverse events (FAERS/openFDA)#

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