FDA.reportPublic FDA data

Algenist

Manufacturer
Solazyme, Inc. | PhytogenX,Inc
Effective date
2019-11-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:56:20

Label at a glance#

ProductAlgenist
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
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 to the entire face, neck, and chest area in the morning or 15 minutes prior to sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor. 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 5.0%

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product, keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

  • Stop use and consult a doctor if rash occurs

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to the entire face, neck, and chest area in the morning or 15 minutes prior to sun exposure.

  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: Ask a doctor.

SPL UNCLASSIFIED SECTION

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 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-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Silica, Butylene Glycol, Pentylene Glycol, Caprylic/Capric Triglyceride, Glycerin, PEG-100 Stearate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Di-C12-15 Alkyl Fumarate, Cetearyl Alcohol, Cetyl Phosphate, Algae Exopolysaccharides, Malus Domestica Fruit (Apple) Cell Culture Extract, Bambusa Vulgaris (Bamboo) Leaf/Stem Extract, Tetrapeptide-21, Pisum Sativum (Pea) Extract, Enantia Chlorantha Bark Extract, Alaria Esculenta Extract, Sodium Ascorbyl Phosphate, Biotin, Glucosamine HCL, Eucalyptus Globulus Leaf Oil, Ergothioneine, Oleanolic Acid, Stearic Acid, Carbomer, Xanthan Gum, Lecithin, Mannitol, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Aminomethyl Propanol, Hexylene Glycol, Phenoxyethanol.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

ANTI-WRINKLE / ANTI-RIDES

Regenerative
Anti-Aging Moisturizer | SPF 20

Soin Régénérant Anti-âge | FPS 20

Broad Spectrum | Ecran Solaire Large Spectre

ALGENIST

formulated with Algurinic Acid

Biotechnology from San Francisco

2 US fl. oz / 60 mL

Principal Display Panel – Carton Label
Principal Display Panel – Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53407-155-602019-12-02C16284748780-19855d018-dc34-cd31-e053-dbdaa90ab51a64952f6a-eea3-4217-bdd1-8b492b945aba
53407-155-602019-11-27C16284748780-19855d018-dc34-cd31-e053-dbdaa90ab51a64952f6a-eea3-4217-bdd1-8b492b945aba

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX3
HomosalateACTIVE INGREDIENTV06SV4M95S3
OctisalateACTIVE INGREDIENT4X49Y0596W3
AvobenzoneACTIVE MOIETYG63QQF2NOX3
HomosalateACTIVE MOIETYV06SV4M95S3
OctisalateACTIVE MOIETY4X49Y0596W3
ALARIA ESCULENTAINACTIVE INGREDIENTEJ9JK8J58D3
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q3
ANNICKIA CHLORANTHA BARKINACTIVE INGREDIENTH70115MP4A3
APPLEINACTIVE INGREDIENTB423VGH5S93
BiotinINACTIVE INGREDIENT6SO6U10H043
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA3
caprylyl glycolINACTIVE INGREDIENT00YIU5438U3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT92083
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3
Cetyl PhosphateINACTIVE INGREDIENTVT07D6X67O3
DI-C12-15 ALKYL FUMARATEINACTIVE INGREDIENTA1CB3Z898P3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV3
ERGOTHIONEINEINACTIVE INGREDIENTBDZ3DQM98W3
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6623
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
hexylene glycolINACTIVE INGREDIENTKEH0A3F75J3
mannitolINACTIVE INGREDIENT3OWL53L36A3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ3
Peg-100 StearateINACTIVE INGREDIENTYD01N1999R3
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG3
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T3
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR3
stearic acidINACTIVE INGREDIENT4ELV7Z65AP3
Tetrapeptide-21INACTIVE INGREDIENT179JUC43HU3
WaterINACTIVE INGREDIENT059QF0KO0R3
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53407-15553407-155-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SHEA BUTTERK49155WL9YIACT
DI-C12-15 ALKYL FUMARATEA1CB3Z898PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PHOSPHATEVT07D6X67OIACT
APPLEB423VGH5S9IACT
TETRAPEPTIDE-21179JUC43HUIACT
ANNICKIA CHLORANTHA BARKH70115MP4AIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
BIOTIN6SO6U10H04IACT
EUCALYPTUS OIL2R04ONI662IACT
ERGOTHIONEINEBDZ3DQM98WIACT
OLEANOLIC ACID6SMK8R7TGJIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
XANTHAN GUMTTV12P4NEEIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
MANNITOL3OWL53L36AIACT
EDETATE DISODIUM7FLD91C86KIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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 7 · 407 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE, EXTENDED RELEASE / ORAL616 mgExact identifier — unii candidate
65 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL / TOPICAL30 mgExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
mannitolMANNITOL3OWL53L36APOWDER / ORAL4352 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36APOWDER / RESPIRATORY (INHALATION)6 mgExact identifier — unii candidate
65 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION, GEL FORMING / DROPS / OPHTHALMIC4 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS180 mgExact identifier — unii candidate
65 equally ranked IID candidates
Peg-100 StearatePEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS658 mgExact identifier — unii candidate
65 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CAPSULE / ORAL32 mgExact identifier — unii candidate
14 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 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
9855a3e9-f565-e7b3-e053-2995a90a798a64952f6a-eea3-4217-bdd1-8b492b945aba2019-11-27WarningsExact identifier
spl id: 9855a3e9-f565-e7b3-e053-2995a90a798a
spl set id: 64952f6a-eea3-4217-bdd1-8b492b945aba

Reported adverse events (FAERS/openFDA)#

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