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Manufacturer: Exelencia Importers Corp | BIOCOSMETICA EXEL ARGENTINA S.R.L.
Effective date: 2012-11-05
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:33:35

Label at a glance#

ProductExel Sunscreen Creme SPF 37

Active ingredientOCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Sunscreen Ingredients

Octocrylene (sunscreen) 5,0%

Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5%

Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0%

Oxybezone (Benzophenone 3) (sunscreen) 3,0%

Titanium Dioxide (sunscreen) 3,0%

OTC - PURPOSE SECTION

Action:

recommend for use in exfoliating treatments with hydroxy acids during summer and, perticularly, when Exel's "Skin Renewal Micro Peel System" is applied.

Helps prevent sunburn

Ultra moisturizing action. Enhanced with Aloe Vera gel, Shea Butter and Vitamin E Acetate.

Dermatologically tested. It does not contain PABA (4-Aminobenzoic Acid).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Stop use if and ask a doctor if rash occurs. If swallowed get medical help or contact a poison control center right away.

WARNINGS SECTION

External use only.

Do not use in on damaged or broken skin.

Contains Oxybenzone.

When using this product, keep out of eyes.

Skin cancer/ Skin aging alert:

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn and not skin cancer and early skin aging.

Limit time in the sun 10 am to 2 p (North Hemisphere).

Wear long-sleeve shirts, pants, hats and sunglasses.

Children should avoid prolonged exposure to sunlight.

Sunscreens do not prevent heat stroke.

Product only available through a professional.

DOSAGE & ADMINISTRATION SECTION

How to use

No water resistant product: Apply Liberally 15 minutes before sun exposure.

Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness.

Children under 6 months: ask a doctor.

Protect this product from excessive heat and sunlight.

INACTIVE INGREDIENT SECTION

INCI Inactive Ingredients

Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin
* Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine
* Fragrance (Parfum) * BHT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of bottle label

Exel

Sun Protection Creme SPF

contains Vitamin E Acetate, Shea Butter, and Aloe Vera Gel.

1.69 fl. oz 50

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53863-120-02	2019-11-27	C162847	48780-1	9855d018-eb58-cd31-e053-dbdaa90ab51a	Sun Protection creme SPF 37

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53863-120-01	ExelSunscreen Creme SPF 37	50 mL in 1 BOTTLE	CREAM	50		3
53863-120-02	ExelSunscreen Creme SPF 37	1 in 1 CARTON	CREAM	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53863-120	SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP]	3	Legacy NDC, 2 package rows	20121106_bfcf87c0-27c4-4fba-9f4e-77e7132e073a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
HAMAMELIS VIRGINIANA TOP	INACTIVE INGREDIENT	UDA30A2JJY	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

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

Exel Sunscreen Creme SPF 37
Octocrylene,Octinoxate,Octisalate,Oxybenzone,Titanium Dioxide
OCTOCRYLENE
OCTINOXATE
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE
WATER
PROPYLENE GLYCOL
GLYCERIN
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
STEARIC ACID
DIMETHICONE
ALOE VERA LEAF
HAMAMELIS VIRGINIANA TOP
POLYSORBATE 20
DMDM HYDANTOIN
METHYLPARABEN
PROPYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
SHEA BUTTER
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53863-120	53863-120-01, 53863-120-02

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
OCTOCRYLENE	5A68WGF6WM	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
CETYL ALCOHOL	936JST6JCN	IACT
STEARIC ACID	4ELV7Z65AP	IACT
DIMETHICONE	92RU3N3Y1O	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
HAMAMELIS VIRGINIANA TOP	UDA30A2JJY	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
SHEA BUTTER	K49155WL9Y	IACT
XANTHAN GUM	TTV12P4NEE	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TROLAMINE	9O3K93S3TK	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	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 9 · 537 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		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
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	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
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 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
dd2e2774-4545-43e7-a423-4c53b97fdfbd			bfcf87c0-27c4-4fba-9f4e-77e7132e073a	2012-11-05	Warnings	Exact identifier spl id: dd2e2774-4545-43e7-a423-4c53b97fdfbd spl set id: bfcf87c0-27c4-4fba-9f4e-77e7132e073a

Reported adverse events (FAERS/openFDA)#

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