Bioelements

Manufacturer: Bioelements Inc. | Bell International Laboratories, Inc.
Effective date: 2012-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:30:46

Label at a glance#

ProductBioelements Sun Diffusing Protector SPF 15

Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Octinoxate 7.5 % Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 3% Sunscreen

Titanium Dioxide 0.01% Sunscreen

zinc Oxide 0.01% Sunscreen

OTC - PURPOSE SECTION

Uses

For skin highly sensitive to sunburn

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash and irritation develops and lasts

WARNINGS SECTION

Warnings

For external use only.

When using this product: keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months, ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Water (aqua) (eau), sorbitol, c12-15 alkyl benzoate, DEA cetyl phosphate, stearic acid, cetyl alcohol, dimethicone, carbomer, Lavendula Augustifolia (Lavender) oil, Salvia Officinalis (sage) Oil, Salvia sclarea (clary sage) oil, Citrus aurantium (petitgrain cordillera) oil, Citrus Aurantium (neroli) oil, Lavendula Hybridia (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-114-02	2020-01-31	C162847	48780-1	9d75b9d0-9796-f424-e053-dadaa90a57ce	Sun Diffusing Protector SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49825-114-01	BioelementsSun Diffusing Protector SPF 15	177 mL in 1 BOTTLE	CREAM	177		6
49825-114-02	BioelementsSun Diffusing Protector SPF 15	1 in 1 BOX	CREAM	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-114	BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]	6	Legacy NDC, 2 package rows	20120127_6550938a-7299-4e4b-aafe-4d5ce13e79a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	6
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	6
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	6
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	6
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	6
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	6
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	6
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	6
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	6
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	6
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	6
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	6
CITRUS AURANTIUM FLOWER OIL	INACTIVE INGREDIENT	D4BGE91OXH	6
CITRUS AURANTIUM FRUIT OIL	INACTIVE INGREDIENT	59JDQ5VT0T	6
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	6
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	6
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	6
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	6
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	6

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Bioelements Sun Diffusing Protector SPF 15
Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
OCTINOXATE
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE
ZINC OXIDE
SORBITOL
ALKYL (C12-15) BENZOATE
STEARIC ACID
CETYL ALCOHOL
DIMETHICONE
LAVENDER OIL
SAGE OIL
CITRUS AURANTIUM FRUIT OIL
CITRUS AURANTIUM FLOWER OIL
IMIDUREA
METHYLPARABEN
PROPYLPARABEN
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49825-114	49825-114-01, 49825-114-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
SORBITOL	506T60A25R	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIMETHICONE	92RU3N3Y1O	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
SAGE OIL	U27K0H1H2O	IACT
CITRUS AURANTIUM FRUIT OIL	59JDQ5VT0T	IACT
CITRUS AURANTIUM FLOWER OIL	D4BGE91OXH	IACT
IMIDUREA	M629807ATL	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TROLAMINE	9O3K93S3TK	IACT

Source Document#

Source XML

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 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	INHALANT / NASAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 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
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 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
19d7afa4-cd7c-4876-91f7-cf916fa73748			6550938a-7299-4e4b-aafe-4d5ce13e79a5	2012-01-12	Warnings	Exact identifier spl id: 19d7afa4-cd7c-4876-91f7-cf916fa73748 spl set id: 6550938a-7299-4e4b-aafe-4d5ce13e79a5

Reported adverse events (FAERS/openFDA)#

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