Seytu Body Sunscreen Cream
FDA Label NDC 84271-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Omnilife Usa, Inc. for the product Seytu Body Sunscreen (NDC 84271-001). 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, purpose, uses, stop use and ask a doctor, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxide8.3%
Zinc Oxide4.875%

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.

Stop Use And Ask A Doctor

if rash occurs.

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

Directions

  • Apply generously 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun.
  • 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sub 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.
  • Reapply: ⦁ after 80 minutes of swimming or sweating. ⦁ Immediately after towel drying ⦁ at least every 2 hours.

Other Information

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

Inactive Ingredients

Aluminum Hydroxide, Aluminum Starch Octenylsuccinate, Aqua (Water), Benzotriazolyl Dodecyl p-Cresol, Benzyl alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cetyl PEG/PPG-10/1 Dimethicone, Dicaprylyl Carbonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Ethylhexyl Olivate, Hydrogenated Farnesene, Hydrogenated Olive Oil Unsaponifiables, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Chloride, Stearic Acid, Tocopherol, Triethoxycaprylylsilane.

Principal Display Panel

SEYTÚ
SPF 50+
50+UVA UVB
HIGH SUN PROTECTION
Body Sunscreen
80 min. Water-resistant
OCEAN RESPECT
REEF SAFE
Net Wt. 4.05 fl. oz. (120 ml)

Principal Display PanelseytÚspf 50+50+uva Uvbhigh Sun Protectionbody Sunscreen80 Min. Water-resistantocean Respectreef Safenet Wt. 4.05 Fl. Oz. (120 mL) (Seytu Body Sunscreen Spf 50 01)

Principal Display PanelseytÚspf 50+50+uva Uvbhigh Sun Protectionbody Sunscreen80 Min. Water-resistantocean Respectreef Safenet Wt. 4.05 Fl. Oz. (120 mL) (Seytu Body Sunscreen Spf 50 01)

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