Vitamin E Moisture-protect Lip Care Spf 15
FDA Label NDC 57691-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Body Shop, Wake Forest for the product Vitamin E Moisture-protect Lip Care Spf 15 (NDC 57691-002). 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 other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

ACTIVE INGREDIENTSPurpose
Avobenzone (2.0% w/w)Sunscreen
Octisalate (5.0% w/w)Sunscreen
Octocrylene (3.0% w/w)Sunscreen

Uses

  • helps prevent sunburn.

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in sun especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • reapply this product at least every 2 hours.
  • use water resistant sunscreen if swimming or sweating.
  • children under 6 months of age: ask a doctor.

Other Information

  • protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hydrogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

Principal Display Panel - 4.2 G Container

THE
BODY
SHOP®

THE BODY SHOP
VITAMIN E
MOISTURE-PROTECT
LIP CARE

BROADSPECTRUM SPF 15
SUNSCREEN

WITH VITAMIN E
& MOISTURISING WHEATGERM OIL

ACTIVE INGREDIENTS:
Avobenzone (2.0%),
Octisalate (5.0%),
Octocrylene (3.0%).

Net wt. 4.2 g (0.14 OZ)

ALL SKIN TYPES

Peel for Drug Facts

Principal Display Panel (4.2 g Container)

Principal Display Panel (4.2 g Container)

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