SEYTU BODY SUNSCREEN- titanium dioxide and zinc oxide cream

SEYTU Body Sunscreen by

Drug Labeling and Warnings

SEYTU Body Sunscreen by is a Otc medication manufactured, distributed, or labeled by Omnilife USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SEYTÚ BODY SUNSCREEN SPF 50+- titanium dioxide, zinc oxide cream

Drug Facts

Active Ingredients

• Titanium Dioxide: 8.3%
• Zinc Oxide: 4.875%

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.

Keep out of reach of children.

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)

INGREDIENTS AND APPEARANCE

SEYTU BODY SUNSCREEN 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84271-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.875 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
GLYCERIN (UNII: PDC6A3C0OX)
FARNESENE (UNII: 4P3OFI15E1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
JOJOBA OIL (UNII: 724GKU717M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
GLYCERYL 2-UNDECYLENATE (UNII: 080YJC95AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84271-001-01	1 in 1 BOX	04/15/2024
1		120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2024

Labeler - Omnilife USA, Inc. (160551441)