Enfuselle Body Sunscreen Broad Spectrum Spf 30 Lotion
FDA Label NDC 59899-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shaklee Corporation for the product Enfuselle Body Sunscreen Broad Spectrum Spf 30 (NDC 59899-007). 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, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts:

Active Ingredients

Homosalate 10%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

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.
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and 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.
      • children under 6 months: Ask a doctor

Inactive Ingredients:

Water/Eau, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Cetyl
PEG/PPG-10/1 Dimethicone,
Cyclopentasiloxane, Microcrystalline
Wax, Cetyl Dimethicone,
Cyclohexasiloxane, Panthenol,
Tocopheryl Acetate, Magnesium
Ascorbyl Phosphate, Beta-Glucan,
Retinyl Palmitate, Vitis Vinifera (Grape)
Seed Extract, Superoxide Dismutase,
Glycerin, Hydrogenated Castor Oil,
Ethylhexylglycerin, Phenyl
Trimethicone, Caprylyl Glycol,
Polyglyceryl-4 Isostearate, Hexyl
Laurate, Sodium Chloride, Silica,
Disodium EDTA, Phenoxyethanol

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

925.734.3638

Principal Display Panel Carton

WATER RESISTANT

PARABEN FREE

4 fl. oz. 118 mL

              All Skin Types

Multipatented formula provides
broad-spectrum SPF 30 protection from
sun’s harmful rays to help reduce the
risk of skin damage. Regular use of this
product may help minimize visible
lines, uneven coloration, dryness, and
dullness associated with sun exposure.
Triple patented Vital Repair+ Complex®
helps disarm free radicals, which can
create prematurely older-looking skin.
Quickly absorbed lotion locks in
moisture without leaving a sticky finish.
Ideal for sensitive skin.

• Contains triple patented
Vital Repair+ Complex®
• Water resistant (80 minutes)
• Designed not to clog pores
• 100% fragrance and
paraben free
• Allergy tested
• Clinically formulated
• Dermatologist tested
• Patented sensitive-skin
formula
• Not tested on animals

Dist. by/par Shaklee Corporation
4747 Willow Road
Pleasanton, CA 94588 USA
Item #32565
Imp. by/par Shaklee Canada Inc.
3100 Harvester Road, Unit 7
Burlington, ON L7N 3W8

Carton (Carton)

Carton (Carton)

Principal Display Panel Tube

Broad-spectrum SPF 30 protection helps shield skin from
sun’s harmful rays. 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.

Directions: Apply generously 15 minutes before
sun exposure.

Tube (Tube)

Tube (Tube)

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