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.
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE
- Manufacturer
- Port Jervis Laboratories, Inc.
- Effective date
- 2025-05-13
- 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 MINT BREEZE SPF 30
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure11 sections
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 along...
Storage and handling
Protect this product from excessive heat and direct sun to prevent degredation of sunscreen ingredients.
Contacts and useful links#
Label contents#
Full prescribing information#
PURPOSE
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.
ACTIVE INGREDIENT
AVOBENZONE 3.0%
HOMOSALATE 7.0%
OCTISALATE 4.5%
OCTOCRYLENE 9.0%
WARNINGS
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
- 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
- Protect this product from excessive heat and direct sun to prevent degredation of sunscreen ingredients.
INACTIVE INGREDIENTS
BEESWAX, OCTYLDODECANOL, BUTYLOCTYL SALICYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, OCTYLDODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PUNICA GRANATUM STEROLS, MENTHA PIPERITA (PEPPERMINT) OIL, TOCOPHERYL ACETATE, RICINUS COMMUNIS (CASTOR) SEED OIL, SODIUM HYALURONATE, HYDROGENATED CASTOR OIL
QUESTIONS?
1-360-245-7283, NATUREWELLBEAUTY.COM, Monday – Friday, 9 AM – 5 PM EST
4.8 PDP
4.8 Carton
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10637-3201-1 | NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 30 | 4.8 g in 1 CYLINDER | LIPSTICK | 4.8 | 1 | |
| 10637-3201-2 | NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 30 | 1 in 1 CARTON | LIPSTICK | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10637-3201 | NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM) LIPSTICK [PORT JERVIS LABORATORIES, INC.] | 1 | Current NDC, 2 package rows | 20250527_350cd329-8fe2-314f-e063-6394a90ac954.zip |
Products#
Every source-derived product name is available through these pages.
- NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30
- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM
- MENTHA PIPERITA (PEPPERMINT) OIL
- BUTYLOCTYL SALICYLATE
- RICINUS COMMUNIS (CASTOR) SEED OIL
- OCTYLDODECANOL
- SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
- OCTYLDODECYL NEOPENTANOATE
- SODIUM HYALURONATE
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- PUNICA GRANATUM STEROLS
- HYDROGENATED CASTOR OIL
- BEESWAX
- .ALPHA.-TOCOPHEROL ACETATE
- OCTISALATE
- HOMOSALATE
- AVOBENZONE
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10637-3201 | 10637-3201-1, 10637-3201-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM | Port Jervis Laboratories, Inc. | 350cd329-8fe2-314f-e063-6394a90ac954 | 2025-05-13 | Warnings | 10637-3201-2 10637-3201-1 10637-3201 10637320101 10637320102 350ccba5-c537-588f-e063-6294a90a4f5c 350cd329-8fe2-314f-e063-6394a90ac954 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.