FDA.reportPublic FDA data

Fresh Skin Organics

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2020-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:29

Label at a glance#

ProductFresh Skin Organics
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide (18%)

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses: Our SPF formulas provide both UVA and UVB

protection, and are infused with antioxidants and nutrients to help

prevent sun damage while keepingthe skin well-hydrated.

WARNINGS SECTION

WARNINGS:

For external use only.

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

If contact with eyes occurs, flush with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops

and persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed,

seek immediate medical attention or contact a Poison Control Center

right away.

For use on children under 6 months: consult a physician.

OTC - QUESTIONS SECTION

Questions? Call 1-800-535-5053

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml30ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-425-002022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-012022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-022022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-042022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-052022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-082022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-092022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-122022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-162022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-282022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-342022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-552022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000
58418-425-642022-01-28C16284748780-1d6a99b39-f19d-a426-e053-dadaa90af4c2Formula: ABNZ2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-425-00Fresh Skin Organics15 mL in 1 PACKETLOTION151
58418-425-01Fresh Skin Organics30 mL in 1 BOTTLE, DISPENSINGLOTION301
58418-425-02Fresh Skin Organics60 mL in 1 BOTTLE, DISPENSINGLOTION601
58418-425-04Fresh Skin Organics120 mL in 1 BOTTLE, DISPENSINGLOTION1201
58418-425-05Fresh Skin Organics15 mL in 1 BOTTLE, DISPENSINGLOTION151
58418-425-08Fresh Skin Organics240 mL in 1 BOTTLE, DISPENSINGLOTION2401
58418-425-09Fresh Skin Organics240 mL in 1 BOTTLE, PUMPLOTION2401
58418-425-12Fresh Skin Organics360 mL in 1 BOTTLE, PUMPLOTION3601
58418-425-16Fresh Skin Organics480 mL in 1 BOTTLE, PUMPLOTION4801
58418-425-28Fresh Skin Organics3840 mL in 1 BOTTLE, PUMPLOTION38401
58418-425-34Fresh Skin Organics100.55 mL in 1 TUBELOTION100.551
58418-425-55Fresh Skin Organics211200 mL in 1 DRUMLOTION2112001
58418-425-64Fresh Skin Organics1920 mL in 1 BOTTLE, PUMPLOTION19201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-425FRESH SKIN ORGANICS (AB NAT ZINC) LOTION [TROPICAL ENTERPRISES INTERNATIONAL, INC.]1Legacy NDC, 13 package rows20200429_a05edd7b-be6f-0f10-e053-2995a90a2b6e.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-42558418-425-00, 58418-425-05, 58418-425-01, 58418-425-02, 58418-425-04, 58418-425-08, 58418-425-09, 58418-425-16, 58418-425-12, 58418-425-64, 58418-425-34, 58418-425-28, 58418-425-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
CASTOR OILD5340Y2I9GIACT
ROSEMARY OIL8LGU7VM393IACT
LAVENDER OILZBP1YXW0H8IACT
KUKUI NUT OILTP11QR7B8RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYL PALMITATE2865993309IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
YELLOW WAX2ZA36H0S2VIACT
LAURIC ACID1160N9NU9UIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
AVOCADO OIL6VNO72PFC1IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIB
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
CAPRYLIC ACIDOBL58JN025IACT
SUNFLOWER OIL3W1JG795YIIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
RASPBERRY SEED OIL9S8867952AIACT
SQUALANEGW89575KF9IACT

Source Document#

Source XML · Source PDF

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
a05edd7b-be70-0f10-e053-2995a90a2b6ea05edd7b-be6f-0f10-e053-2995a90a2b6e2020-03-08WarningsExact identifier
spl id: a05edd7b-be70-0f10-e053-2995a90a2b6e
spl set id: a05edd7b-be6f-0f10-e053-2995a90a2b6e

Reported adverse events (FAERS/openFDA)#

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