FDA.reportPublic FDA data

Biossance Squalane Moisturizer

Manufacturer
Amyris, Inc
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:49:50

Label at a glance#

ProductBiossance Squalane Moisturizer SPF30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn if used as directed with other sun protection measures(see ​directions) ​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Dosage and administration

 Apply generously 15 minutes before sun exposure reapply at least  every 2 hours ​Sun Protection Measures   ​Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including  Limit time in the sun, especially from 10 a.m.- 2 p.m. wear long-sleeved shiirts,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

if used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Warnings

WARNINGS SECTION

  For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged of broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove

Stop use and ask

OTC - STOP USE SECTION

a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  •  Apply generously 15 minutes before sun exposure
  • reapply at least  every 2 hours
  • ​Sun Protection Measures   ​Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including
  •  Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • wear long-sleeved shiirts, pants, hats and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age:ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Dipropylene Glycol, Sorbitan Olivate, Cetyl Palmitate, Coco Glucoside, Phenoxyethanol, Sodium Palmitoyl Proline, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, Butylene Glycol, Nymphaea Alba Flower Extract, Ethylhexylglycerin, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate, Glucose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FigureFigure

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73517-381-012025-12-01C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555
73517-381-022025-12-01C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555
73517-381-032025-12-01C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555
73517-381-012025-01-30C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555
73517-381-022025-01-30C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555
73517-381-032025-01-30C16284748780-12cef2736-a068-d83d-e063-dadaa90ab31fee62c442-742f-44e9-b58b-e3d901bc9555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73517-381BIOSSANCE SQUALANE MOISTURIZER SPF30 (ZINC OXIDE) LOTION [AMYRIS, INC]4Legacy NDC20221104_ee62c442-742f-44e9-b58b-e3d901bc9555.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73517-38173517-381-01, 73517-381-02, 73517-381-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SORBITAN OLIVATEMDL271E3GRIACT
CETYL PALMITATE5ZA2S6B08XIACT
COCO GLUCOSIDEICS790225BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM PALMITOYL PROLINE64L053FRFOIACT
ETHYL FERULATE5B8915UELWIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NYMPHAEA ALBA FLOWER40KQ7Q535OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACACIA SENEGAL WHOLEQP4QYZ033CIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM GLUCONATER6Q3791S76IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
445eb35f-c932-be8b-e063-6294a90a6b29ee62c442-742f-44e9-b58b-e3d901bc95552025-11-24WarningsExact identifier
spl set id: ee62c442-742f-44e9-b58b-e3d901bc9555

Reported adverse events (FAERS/openFDA)#

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