FDA.reportPublic FDA data

NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ

Manufacturer
Port Jervis Laboratories, Inc.
Effective date
2025-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:32

Label at a glance#

ProductNATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure11 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 and generously 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. 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 15 value or higher alon...

Storage and handling

Protect this product from excessive heat and direct sun to prevent degredation of sunscreen ingredients.

Label contents#

Full prescribing information#

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 SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 4.5%

OCTOCRYLENE 9.0%

WARNINGS

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

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 or irritation 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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and generously 15 minutes before sun exposure.
  • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.
  • 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 15 value or higher along with other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun to prevent degredation of sunscreen ingredients.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

BEESWAX, OCTYLDODECANOL, BUTYLOCTYL SALICYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, OCTYLDODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PUNICA GRANATUM STEROLS, TOCOPHERYL ACETATE, FLAVOR (AROMA), RICINUS COMMUNIS (CASTOR) SEED OIL, SODIUM HYALURONATE, HYDROGENATED CASTOR OIL

QUESTIONS?

OTC - QUESTIONS SECTION

1- 360-245-7283, NATUREWELLBEAUTY.COM, Monday – Friday, 9 AM – 5 PM EST

4.8 STICK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZNATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ

4.8 CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZNATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10637-3200-1NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ4.8 g in 1 CYLINDERLIPSTICK4.81
10637-3200-2NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10637-3200NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM) LIPSTICK [PORT JERVIS LABORATORIES, INC.]1Current NDC, 2 package rows20250527_350b4cce-1627-5b8f-e063-6294a90aa6bf.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10637-320010637-3200-1, 10637-3200-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
OCTYLDODECANOL461N1O614YIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
PUNICA GRANATUM STEROLSUKV92KC49TIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BEESWAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
ndc (package): 10637-3200-1
ndc (package): 10637-3200-2
ndc (product): 10637-3200
ndc11 (package): 10637320002
ndc11 (package): 10637320001
spl id: 350b4cce-1628-5b8f-e063-6294a90aa6bf
spl set id: 350b4cce-1627-5b8f-e063-6294a90aa6bf

Reported adverse events (FAERS/openFDA)#

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