SQUALANE ZINC SHEER MINERAL SUNSCREEN

Manufacturer
Amyris, Inc
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:30

Label at a glance#

ProductSQUALANE ZINC SHEER MINERAL SUNSCREEN
Active ingredientZINC OXIDE
Label structure6 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 signs of 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 ask a doctor if rash occurs Keep out of reach of children if product is swallwed get medical hel...

Dosage and administration

Helps prevent sunburn if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of 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 ask a doctor if rash occurs Keep out of reach of children if product is swallwed get medical hel...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SecondarySecondary

Purpose

OTC - PURPOSE SECTION

Zinc Oxide 14% Sunscreen

Uses Warnings Directions

OTC - ASK DOCTOR SECTION

Helps prevent sunburn

if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of 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 ask a doctor if rash occurs

Keep out of reach of children if product is swallwed get medical help or contact Poison Control Center right away

Directions

apply generously 15 minutes before sun exposure. reapply at least every 2 hours

Sun Protection Measures

Spendign 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 value of SPF 15 or higher and other sun protections measures including: limit time in the sun, especially from 10 am - 2pm

wear long-sleeved shirts, 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

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

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

50 mL NDC 73517-125-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

secondarysecondary

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73517-125-012024-01-30C16284748780-11030e365-6508-111a-e063-dadaa90a10e2SQUALANE + ZINC SHEER MINERAL SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73517-125-01SQUALANE ZINC SHEER MINERAL SUNSCREEN50 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73517-125SQUALANE ZINC SHEER MINERAL SUNSCREEN CREAM [AMYRIS, INC]3Legacy NDC, 1 package rows20220109_a525b24e-4ced-d47a-e053-2a95a90ad678.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73517-12573517-125-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
d509651b-4af5-8ae8-e053-2a95a90a042aa525b24e-4ced-d47a-e053-2a95a90ad6782022-01-07Exact identifier
spl id: d509651b-4af5-8ae8-e053-2a95a90a042a
spl set id: a525b24e-4ced-d47a-e053-2a95a90ad678

Reported adverse events (FAERS/openFDA)#

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