Slmd Moisturizer With Spf
FDA Label NDC 59958-403

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences, Inc. for the product Slmd Moisturizer With Spf (NDC 59958-403). 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 active ingredients, uses, warningsfor external use only, keep out of reach of children., directions, other information, inactive ingredients, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octinoxate      7.50%
Oxybenzone    3.50%
Avobenzone    2.50%
Octisalate        1.50%

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

Warningsfor External Use Only

Do not use on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating:
  • immediately after towel drying
  • at least every two hours
  • children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thsi 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

Other Information

  • protect this product in this containerfrom excessive heat and direct sun
  • may stain some fabrics

Inactive Ingredients

Water
Emulsifying Wax NF
Cetyl Alcohol
Glycerin
DEA-Cetyl Phosphate
Dimethicone
Behentrimonium Methosulfate
Cetearyl Alcohol
Myristoyl Pentapeptide-17
Myristoyl Tetrapeptide-13
Ascorbyl Linoleate
Retinyl Linoleate
Lysophosphatidic acid
Panthenol
Allantoin
Arginine
Beta-Glucan
Sodium Carboxymethyl Beta-Glucan
Ethyl Macadamiate
Borago Officinalis Seed Oil
Triticum Vulgare (Wheat) Germ Oil
Tocopheryl Acetate
Retinyl Palmitate
Citrus Paradisi (Grapefruit) Fruit Extract
Camellia Sinensis Leaf Extract
Rosa Canina Fruit Extract
Hamamelis Virginiana (Witch Hazel) Extract
Polyglyceryl-3 Polyricinoleate
Polyglyceryl 5 Oleate
PPG-2 Myristyl Ether Propionate
Pentaerythrityl Tetracaprylate/Tetracaprate
Disodium EDTA
Caprylyl Glycol
Phenoxyethanol

Do Not Use

  • on damaged or broken skin

Stop Us And Ask A Doctor If

irritation becomes severe

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Daily Moisturizer Back.jpg

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