Spf 30 Face Moisturizer
FDA Label NDC 53634-255

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Malin And Goetz Inc for the product Spf 30 Face Moisturizer (NDC 53634-255). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient        Purpose

Avobenzone 3%        sunscreen

Homosalate 10%      sunscreen

Octinoxate 7.5%       sunscreen

Octisalate 2.75%      sunscreen

Oxybenzone 5%       sunscreen

Otc - Purpose

Uses

  • Helps prevent sunburn
    • If used as directed with other sun proctection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
    • Retains SPF up to 80 minutes of activity in the water

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if:  Rash or irritation develops and lasts.

Warnings

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.

Dosage & Administration

Directions

  • Apply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed.
  • Re-apply at least every 2 hours; after 80 minutes of  swimming or perspiring; immediately after towel drying.
  • Children under 6 months of age, consult your physician
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  •   Limit time in the sun from 10am-2pm
  • wear long sleeve shirts, pants, hats and sunglasses

Inactive Ingredient

Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/Eicosene Copolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii (shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Calcium Pantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40 Stearate, Phenoxyethanol

Package Label.Principal Display Panel

(Malin + Goetz)

SPF 30 Face Moisturizer

Broad Spectrum SPF 30 All skin types

Water Resistant

1.7 fl. oz. 50 ml

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