Physical Daily Defense Broad Spectrum Sunscreen Spf 40 Cream
FDA Label NDC 72957-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Private Label Skin Care for the product Physical Daily Defense Broad Spectrum Sunscreen Spf 40 (NDC 72957-009). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Zinc Oxide 17%

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

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

Directions

• Apply liberally on a clean dry face, avoiding delicate eye area 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 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 the sun, especially from 10 a.m.– 2 p.m • wear long-sleeved shirts pants, hats, and sunglasses • 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

Water/Aqua/Eau, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Guar (Cyamopsis Tetragonoloba) Gum, Glycerin, Shea (Butyrospermum Parkii) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum

Packaging

Sunscreen (72957 009)

Sunscreen (72957 009)

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