Broad Spectrum SPF 50 Sunscreen

Manufacturer: Bioelements | Cosmetic Enterprises
Effective date: 2014-12-18
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:41:29

Label at a glance#

ProductBroad Spectrum SPF 50 Sunscreen Bioelements

Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Avobenzone 3.0% Sunscreen
Homosalate 10% Sunscreen

Octinoxate 7.0% Sunscreen

Octisalate 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 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

secondary

jar

Bioelements

Used in Professional Facials

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunscreen

Daily antioxidant moisturizer

Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

68 mL/ 2.3 Fl. Oz.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-133-02	2020-01-31	C162847	48780-1	9d75b9d0-596b-f424-e053-dadaa90a57ce	SPF 50 FaceScreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49825-133-01	Broad Spectrum SPF 50 SunscreenBioelements	68 mL in 1 JAR	CREAM	68		5
49825-133-02	Broad Spectrum SPF 50 SunscreenBioelements	1 in 1 BOX	CREAM	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-133	BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]	5	Legacy NDC, 2 package rows	20150128_51259d41-610c-4372-91ba-2f4c02e9b42d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	5
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	5
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	5
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	5
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	5
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	5
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	5
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	5
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	5
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	5
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	5
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	5
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	5
1,3-BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	5
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	5
ANGELICA SINENSIS ROOT	INACTIVE INGREDIENT	B66F4574UG	5
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	5
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	5
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	5
CENTELLA ASIATICA	INACTIVE INGREDIENT	7M867G6T1U	5
CETYL DIMETHICONE 25	INACTIVE INGREDIENT	U4AS1BW4ZB	5
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	5
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	5
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	5
NASTURTIUM OFFICINALE	INACTIVE INGREDIENT	YH89GMV676	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	5
RHUS GLABRA BARK	INACTIVE INGREDIENT	7XC0E9WP6U	5
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	5
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	5
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	5
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

Broad Spectrum SPF 50 Sunscreen Bioelements
Avobenzone, Homosalate, Ocinoxate, Octisalate, Octocrylene, Oxybenzone
AVOBENZONE
HOMOSALATE
OCTINOXATE
OCTISALATE
OCTOCRYLENE
OXYBENZONE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
ALOE VERA LEAF
ANGELICA SINENSIS ROOT
ASCORBYL PALMITATE
1,3-BUTYLENE GLYCOL
CENTELLA ASIATICA
CETYL DIMETHICONE 25
CHAMOMILE
CHLORPHENESIN
EDETATE DISODIUM
GLYCERIN
NASTURTIUM OFFICINALE
ASIAN GINSENG
PHENOXYETHANOL
EGG PHOSPHOLIPIDS
VITAMIN A PALMITATE
RHUS GLABRA BARK
STEARETH-2
STEARETH-21
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49825-133	49825-133-01, 49825-133-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ANGELICA SINENSIS ROOT	B66F4574UG	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
1,3-BUTYLENE GLYCOL	3XUS85K0RA	IACT
CENTELLA ASIATICA	7M867G6T1U	IACT
CETYL DIMETHICONE 25	U4AS1BW4ZB	IACT
CHAMOMILE	FGL3685T2X	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
NASTURTIUM OFFICINALE	YH89GMV676	IACT
ASIAN GINSENG	CUQ3A77YXI	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
RHUS GLABRA BARK	7XC0E9WP6U	IACT
STEARETH-2	V56DFE46J5	IACT
STEARETH-21	53J3F32P58	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARETH-2	STEARETH-2	V56DFE46J5	OINTMENT / TOPICAL		714 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARETH-21	STEARETH-21	53J3F32P58	CREAM / TOPICAL	3 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
1,3-BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
511ea5f5-7cbd-495f-b252-fbe14ae0bf7c			51259d41-610c-4372-91ba-2f4c02e9b42d	2014-12-18	Warnings	Exact identifier spl id: 511ea5f5-7cbd-495f-b252-fbe14ae0bf7c spl set id: 51259d41-610c-4372-91ba-2f4c02e9b42d

Reported adverse events (FAERS/openFDA)#

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