Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40

Manufacturer: Samhealthyskin.COM LLC | Art Nouveau
Effective date: 2015-08-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:43:16

Label at a glance#

ProductSamhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40

Active ingredientTITANIUM DIOXIDE

Label structure9 sections

Indications and 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.

Dosage and administration

For sunscreen use Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: Limit time in th...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS AND PRECAUTIONS SECTION

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.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating

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 value 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

Children under 6 months of age: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, MINERAL OIL, CYCLOMETHICONE, PROPYLENE GLYCOL, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, TALC, IRON OXIDES, HYALURONIC ACID, BEESWAX, MICROCRYSTALLINE WAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, TRIBEHENIN, SORBITAN SESQUIOLEATE, SOLUBLE COLLAGEN, TOCOPHERYL ACETATE, ALLANTOIN, TEA (CAMELLIA SINENSIS) LEAF EXTRACT, WHITE MULBERRY (MORUS ALBA) BARK EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) ROOT EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, DISODIUM EDTA, RED GINSENG (PANAX GINSENG)EXTRACT, SODIUM CHLORIDE, FRAGRANCE

Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40 1.69oz/50ml (57650-159-79)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer

Inner

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57650-159-79	2020-01-31	C162847	48780-1	9d75b9d0-795a-f424-e053-dadaa90a57ce	Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57650-159-79	Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40	50 mL in 1 BOTTLE, PUMP	CREAM	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57650-159	SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40 (TITANIUM DIOXIDE) CREAM [SAMHEALTHYSKIN.COM LLC]	4	Legacy NDC, 1 package rows	20150811_97a7e1b3-bd03-4d0e-9809-b2d03afd8bee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	4
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	4
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	4
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	4
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	4
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	4
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	4
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	4
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	4
LICORICE	INACTIVE INGREDIENT	61ZBX54883	4
MARINE COLLAGEN, SOLUBLE	INACTIVE INGREDIENT	8JC99XGU4W	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
MORUS ALBA BARK	INACTIVE INGREDIENT	7O71A48NDP	4
POLYETHYLENE GLYCOL 500	INACTIVE INGREDIENT	761NX2Q08Y	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	4
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	4
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	4

Products#

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

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

Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40
TITANIUM DIOXIDE
WATER
MINERAL OIL
CYCLOMETHICONE
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 500
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
TALC
FERRIC OXIDE RED
HYALURONIC ACID
YELLOW WAX
MICROCRYSTALLINE WAX
SHEA BUTTER
TRIBEHENIN
SORBITAN SESQUIOLEATE
MARINE COLLAGEN, SOLUBLE
.ALPHA.-TOCOPHEROL ACETATE
ALLANTOIN
GREEN TEA LEAF
MORUS ALBA BARK
LICORICE
GLYCYRRHIZINATE DIPOTASSIUM
METHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN
EDETATE DISODIUM
ASIAN GINSENG
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57650-159	57650-159-79

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
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLYETHYLENE GLYCOL 500	761NX2Q08Y	IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	V2W71V8T0X	IACT
TALC	7SEV7J4R1U	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYALURONIC ACID	S270N0TRQY	IACT
YELLOW WAX	2ZA36H0S2V	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
SHEA BUTTER	K49155WL9Y	IACT
TRIBEHENIN	8OC9U7TQZ0	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
MARINE COLLAGEN, SOLUBLE	8JC99XGU4W	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALLANTOIN	344S277G0Z	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
MORUS ALBA BARK	7O71A48NDP	IACT
LICORICE	61ZBX54883	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ASIAN GINSENG	CUQ3A77YXI	IACT
SODIUM CHLORIDE	451W47IQ8X	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 10 · 565 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 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
dfee0bad-f3e1-42d2-a932-89e3e9e90fd9			97a7e1b3-bd03-4d0e-9809-b2d03afd8bee	2015-08-11	Warnings	Exact identifier spl id: dfee0bad-f3e1-42d2-a932-89e3e9e90fd9 spl set id: 97a7e1b3-bd03-4d0e-9809-b2d03afd8bee

Reported adverse events (FAERS/openFDA)#

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