TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 Sunscreen

Manufacturer
Allergan, Inc.
Effective date
2013-04-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:27:58

Label at a glance#

ProductTOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 Sunscreen
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE
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

apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating, at least every 2 hours, or after towel drying to avoid lowering protection Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection me...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 6.0%

Octinoxate 7.5%

Octisalate 5.0%

Zinc Oxide 10.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply after 80 minutes of swimming or sweating, at least every 2 hours, or after towel drying to avoid lowering protection
  • Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a m -2 p.m., and wearing protective clothing
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Niacinamide, Silica. Glyceryl Stearate. PEG-100 StearatB. Ceteaiyl Alcohol. Squalane, Polygonum Aviculare Extract Physalis Angulata Extract, Dunaliella Salina Extract. Ubiquinone, Glycerin. Camellia Sinensis Leaf Extract Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone. Batyl Alcohol. C12-15 Alkyl Benzoate, Butylene Glycol. Ceteareth-20. Polyhydroxystearic Acid, Isostearic Acid, Acrylates Copolymer, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA. Caprylyl Glycol, Sorbic Acid, Phenoxyethanol

Other information

OTC - QUESTIONS SECTION

  • protect the product in this container from excessive heat and direct sun
  • store at room temperature 15°- 30°C (59°- 86°F)

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOTAL DEFENSE
+
REPAIR
Broad Spectrum SPF 50+ Sunscreen
Water Resistant (80 Minutes)
+ INFRARED PROTECTION
Net Wt. 6 x 1.0 Oz Travel

TOTAL DEFENSE + REPAIR Broad Spectrum SPF 50+ Sunscreen Water Resistant (80 Minutes) + INFRARED PROTECTION Net Wt. 6 x 1.0 Oz TravelTOTAL DEFENSE + REPAIR Broad Spectrum SPF 50+ Sunscreen Water Resistant (80 Minutes) + INFRARED PROTECTION Net Wt. 6 x 1.0 Oz Travel

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
HomosalateACTIVE MOIETYV06SV4M95S1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
.Alpha.-Tocopherol Acetate, D-INACTIVE INGREDIENTA7E6112E4N1
2'-HydroxyacetophenoneINACTIVE INGREDIENT3E533Z76W01
BatilolINACTIVE INGREDIENT39YR661C4U1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D31
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
Dunaliella SalinaINACTIVE INGREDIENTF4O1DKI9A61
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl Stearate SEINACTIVE INGREDIENTFCZ5MH785I1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B01
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P91
Isostearic AcidINACTIVE INGREDIENTX33R8U00621
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U1
Melanin Synthetic (tyrosine, Peroxide)INACTIVE INGREDIENTO0CV1RMR441
NiacinamideINACTIVE INGREDIENT25X51I8RD41
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Physalis AngulataINACTIVE INGREDIENTW4TKW9D5GG1
Polygonum Aviculare TopINACTIVE INGREDIENTZCD6009IUF1
Polyhydroxystearic Acid (2300 Mw)INACTIVE INGREDIENTYXH47AOU0F1
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUY1
Sorbic AcidINACTIVE INGREDIENTX045WJ989B1
SqualeneINACTIVE INGREDIENT7QWM220FJH1
Styrene/Acrylamide Copolymer (MW 500000)INACTIVE INGREDIENT5Z4DPO246A1
TocopherolINACTIVE INGREDIENTR0ZB2556P81
UbidecarenoneINACTIVE INGREDIENTEJ27X76M461
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-55010023-5501-03, 0023-5501-01, 0023-5501-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 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 · 259 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
Polyoxyl 20 Cetostearyl EtherPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSPRAY / TOPICAL2.42 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
Glyceryl Stearate SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii candidate
19 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
Isostearic AcidISOSTEARIC ACIDX33R8U0062GEL / TOPICAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 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
4fce45e1-22af-4fe9-ae90-6acf8d48005154164461-0c04-433c-8675-3df8cd2ad0482013-04-01WarningsExact identifier
spl set id: 54164461-0c04-433c-8675-3df8cd2ad048

Reported adverse events (FAERS/openFDA)#

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