Sheltered Broad Spectrum SPF 55 Sunscreen

Manufacturer: AMCOL Health & Beauty Solutions, Inc. DBA
Effective date: 2015-08-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:43:33

Label at a glance#

ProductSheltered Broad Spectrum SPF 55 Sunscreen

Active ingredienthomosalate, oxybenzone, octisalate, avobenzone, octocrylene

Label structure8 sections

Dosage and administration

Apply liberally 15 minutes prior to sun exposure to face, neck and areas exposed to the sun. Re-apply after swimming, sweating or after 2 hours.

Contacts and useful links#

Websitewww.dermafaith.com

www.dermafaith.com

Websitewww.amcolhpc.com

www.amcolhpc.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

HBS Code (Labeler): FP15501-50.1

Distributor: Derma Faith

Human OTC Drug

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

________________________________________________________

OTC - PURPOSE SECTION

sheltered

broad spectrum

spf 55 sunscreen

derma faith

50 ml/1.7 fl oz

sheltered

broad spectrum

spf 55 sunscreen

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes prior to sun exposure to face, neck and areas exposed to the sun. Re-apply after swimming, sweating or after 2 hours.

Warning:

WARNINGS SECTION

For external use only. UV exposure from the sun increases your risk of skin cancer and early skin aging. To reduce risk, limit time in the sun, wear protective clothing and use a broad spectrum sunscreen of SPF15 of higher.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. If rash occurs discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Derma Faith, LLC
5701 W. Slaughter Lane
A130 #337
Austin, TX 78749
Made in the U.S.A.
www.dermafaith.com
M050829

This extra care sunscreen features our patented Polargel® UV SPF boosting technology that enables improved sunscreen performance with lower sunscreen actives. Formulated with antioxidants to help fight free radicals, this non-greasy formulation provides broad-spectrum sun protection without feeling thick or oily.

Active ingredients:

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Abies Wood Extract, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glucose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol

________________________________________________________

150831

AMCOL Health & Beauty Solutions, Inc. DBA
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
lauren.haase@amcol.com

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sheltered

broad spectrum
spf 55 sunscreen

derma
faith

50 ml/1.7 fl oz.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Bottle Label

sheltered

broad spectrum sunscreen spf 55

derma
faith

50 ml/1.7 fl oz.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68634-050-01	2020-01-31	C162847	48780-1	9d75b9d0-7a3b-f424-e053-dadaa90a57ce	Sheltered Broad Spectrum Sunscreen SPF 55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68634-050-01	Sheltered Broad Spectrum SPF 55 Sunscreen	1 in 1 CARTON	LIQUID	1		1
68634-050-01	Sheltered Broad Spectrum SPF 55 Sunscreen	50 mL in 1 BOTTLE	LIQUID	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68634-050	SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA]	1	Legacy NDC, 2 package rows	20150909_c8d1be79-a585-4e04-ade2-4ee6d8e962a6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	1
homosalate	ACTIVE INGREDIENT	V06SV4M95S	1
octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
avobenzone	ACTIVE MOIETY	G63QQF2NOX	1
homosalate	ACTIVE MOIETY	V06SV4M95S	1
octisalate	ACTIVE MOIETY	4X49Y0596W	1
octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
.alpha.-tocopherol acetate, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
bentonite	INACTIVE INGREDIENT	A3N5ZCN45C	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
carbomer copolymer type A	INACTIVE INGREDIENT	71DD5V995L	1
chlorphenesin	INACTIVE INGREDIENT	I670DAL4SZ	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	1
high density polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
picea abies wood	INACTIVE INGREDIENT	72GZ8K8996	1
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium ascorbyl phosphate	INACTIVE INGREDIENT	836SJG51DR	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
sodium polyacrylate (8000 mw)	INACTIVE INGREDIENT	285CYO341L	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	1
vitamin a palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Sheltered Broad Spectrum SPF 55 Sunscreen
homosalate, oxybenzone, octisalate, avobenzone, octocrylene
homosalate
oxybenzone
octisalate
avobenzone
octocrylene
water
butylene glycol
polyethylene glycol 400
high density polyethylene
dimethicone
silicon dioxide
picea abies wood
sodium ascorbyl phosphate
vitamin a palmitate
tocopherol
.alpha.-tocopherol acetate, DL-
titanium dioxide
aloe vera leaf
bentonite
carbomer copolymer type A
sodium polyacrylate (8000 mw)
kaolin
ethylhexylglycerin
edetate disodium
sodium hydroxide
chlorphenesin
phenoxyethanol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68634-050	68634-050-01

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
Name	UNII	Kind
homosalate	V06SV4M95S	ACTIB
oxybenzone	95OOS7VE0Y	ACTIB
octisalate	4X49Y0596W	ACTIB
avobenzone	G63QQF2NOX	ACTIB
octocrylene	5A68WGF6WM	ACTIB
water	059QF0KO0R	IACT
butylene glycol	3XUS85K0RA	IACT
polyethylene glycol 400	B697894SGQ	IACT
high density polyethylene	UG00KM4WR7	IACT
dimethicone	92RU3N3Y1O	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
picea abies wood	72GZ8K8996	IACT
sodium ascorbyl phosphate	836SJG51DR	IACT
vitamin a palmitate	1D1K0N0VVC	IACT
tocopherol	R0ZB2556P8	IACT
.alpha.-tocopherol acetate, DL-	WR1WPI7EW8	IACT
titanium dioxide	15FIX9V2JP	IACT
aloe vera leaf	ZY81Z83H0X	IACT
bentonite	A3N5ZCN45C	IACT
carbomer copolymer type A	71DD5V995L	IACT
sodium polyacrylate (8000 mw)	285CYO341L	IACT
kaolin	24H4NWX5CO	IACT
ethylhexylglycerin	147D247K3P	IACT
edetate disodium	7FLD91C86K	IACT
sodium hydroxide	55X04QC32I	IACT
chlorphenesin	I670DAL4SZ	IACT
phenoxyethanol	HIE492ZZ3T	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 8 · 435 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
bentonite	BENTONITE	A3N5ZCN45C	SYSTEM / TRANSDERMAL	9.86 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	ELIXIR / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
tocopherol	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / ORAL		9120 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
kaolin	KAOLIN	24H4NWX5CO	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
kaolin	KAOLIN	24H4NWX5CO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / TOPICAL		39 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		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
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAMUSCULAR	176 mg		Exact identifier — unii candidate 174 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
8cc522b4-c4f9-40f6-b24c-f58ea9eb8b0c			c8d1be79-a585-4e04-ade2-4ee6d8e962a6	2015-08-31	Warnings	Exact identifier spl id: 8cc522b4-c4f9-40f6-b24c-f58ea9eb8b0c spl set id: c8d1be79-a585-4e04-ade2-4ee6d8e962a6

Reported adverse events (FAERS/openFDA)#

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