Naturewell Hydrasun Lip Balm Spf30 Mint Breeze Lipstick
FDA Label NDC 10637-3201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Port Jervis Laboratories, Inc. for the product Naturewell Hydrasun Lip Balm Spf30 Mint Breeze (NDC 10637-3201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, uses, active ingredient, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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Naturewell Hydrasun Lip Balms Spf30 Mint Breeze (Mint)

Naturewell Hydrasun Lip Balms Spf30 Mint Breeze (Mint)

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