Sunscreen Broad Spectrum SPF 50

Manufacturer
Vitality Institute Medical Products | VEGE-KURL, INC
Effective date
2015-04-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:42:16

Label at a glance#

ProductSunscreen Broad Spectrum SPF 50 Vitality Institute
Active ingredientZINC OXIDE, OCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients             Purpose

Zinc Oxide  10% ............... Sunscreen

Octinoxate 7.5% .............. 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 swallowed, get 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
  • When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION SECTION


Directions

  • Apply evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours or after towel drying, swimming or sweating
  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am-2pm

  • wear long-sleeved shirts, pants, hats, and sunglasses

  • children under 6 months of age: Askj a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitaliy Institute Skin Care System

SPF 50+

Sunscreen Broad Spectrum

2 FL OZ/306mL

2 FL OZ2 FL OZ

1 FL OZ1 FL OZ

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130852180003131GTIN-13: 0852180003131
EAN-13: 0852180003131
GTIN-12: 852180003131
UPC-A: 852180003131
GTIN storage (14 digits): 00852180003131
SPF2oz_2014O - 1L.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69718-155-022020-01-31C16284748780-19d75b9d0-c961-f424-e053-dadaa90a57ceVitality Institute Skin Care System SPF 50+
69718-155-042020-01-31C16284748780-19d75b9d0-c961-f424-e053-dadaa90a57ceVitality Institute Skin Care System SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69718-155-01Sunscreen Broad Spectrum SPF 50Vitality Institute30 mL in 1 TUBECREAM307
69718-155-02Sunscreen Broad Spectrum SPF 50Vitality Institute1 in 1 BOXCREAM17
69718-155-03Sunscreen Broad Spectrum SPF 50Vitality Institute59 mL in 1 TUBECREAM597
69718-155-04Sunscreen Broad Spectrum SPF 50Vitality Institute1 in 1 BOXCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69718-155SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]7Legacy NDC, 4 package rows20150410_507c46c3-3fd8-491e-850c-3060c7f488cd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD517
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z7
OCTINOXATEACTIVE MOIETY4Y5P7MUD517
ZINC CATIONACTIVE MOIETY13S1S8SF377
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH7
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ7
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S7
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG7
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99H7
COCONUT ALKANESINACTIVE INGREDIENT1E5KJY107T7
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K7
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P7
GlycerinINACTIVE INGREDIENTPDC6A3C0OX7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE47
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B07
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T7
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R7
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T7
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F7
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M7
PUERARIA MONTANA VAR. LOBATA ROOTINACTIVE INGREDIENTPET93F4I3C7
PUMMELOINACTIVE INGREDIENTET1TN5W71X7
WATERINACTIVE INGREDIENT059QF0KO0R7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE7

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69718-15569718-155-01, 69718-155-02, 69718-155-03, 69718-155-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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 · 289 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b9a1d098-9d70-40fd-a3ec-cac0522330db507c46c3-3fd8-491e-850c-3060c7f488cd2015-04-10WarningsExact identifier
spl id: b9a1d098-9d70-40fd-a3ec-cac0522330db
spl set id: 507c46c3-3fd8-491e-850c-3060c7f488cd

Reported adverse events (FAERS/openFDA)#

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