Algenist by Solazyme, Inc. / PhytogenX,Inc

Algenist by

Drug Labeling and Warnings

Algenist by is a Otc medication manufactured, distributed, or labeled by Solazyme, Inc., PhytogenX,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALGENIST- avobenzone, homosalate, octisalate cream 
Solazyme, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 5.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

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.

Warnings

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 consult a doctor if rash occurs

• Keep out of reach of children
• If swallowed, get medical help or contact a poison control center right away.

Directions

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 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

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

Protect this product from excessive heat and direct sun.

Questions Call toll free 1-877-650-1837

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

ALGENIST 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53407-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SHEA BUTTER (UNII: K49155WL9Y)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PHOSPHATE (UNII: VT07D6X67O)
APPLE (UNII: B423VGH5S9)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
BIOTIN (UNII: 6SO6U10H04)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
XANTHAN GUM (UNII: TTV12P4NEE)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANNITOL (UNII: 3OWL53L36A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53407-155-60	1 in 1 BOX	08/01/2012
1		1 in 1 CARTON
1		60 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - Solazyme, Inc. (145862012)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX,Inc		624386772	manufacture(53407-155)

Revised: 11/2019

Document Id: 9855a3e9-f565-e7b3-e053-2995a90a798a

34390-5

Set id: 64952f6a-eea3-4217-bdd1-8b492b945aba

Version: 5

Effective Time: 20191127

 

Solazyme, Inc.