SEI BELLA DAILY UV DEFENSE BROAD-SPECTRUM SPF 25 SUNSCREEN- sunscreen cream

Sei Bella Daily UV Defense by

Drug Labeling and Warnings

Sei Bella Daily UV Defense by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 7.5%
Octocrylene 9%
Octisalate 3.75%
Titanium Dioxide 2%
Zinc Oxide 9.45%

PURPOSE

sunscreen

INDICATIONS & USAGE

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun

Warnings

For external use only. Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

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.

DOSAGE & ADMINISTRATION

Directions For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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:

limiting time in the sun, especially from 10 a.m. - 2 p.m.

wearing long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

STORAGE AND HANDLING

store at room temperature 68-77 F. Protect from freezing.

INACTIVE INGREDIENT

water, caprylyl methicone, cyclopentasiloxane, glycerin, caprylic/capric triglyceride, coco-caprylate/caprate, propanediol, pyrus malus (apple) fruit extract, dimethicone, polymethylsilsesquioxane, lauryl peg-9 polydimethylsiloxyethyl dimethicone, PEG-12 dimethicone/PPG-20 crosspolymer, acrylates/dimethicone copolymer, C12-15 alkyl benzoate, polyhydroxystearic acid, dimethicone/peg-10/15 crosspolymer, gossypium hirsutum (cotton) extract, sodium chloride, phenoxyethanol, triethoxycaprylylsilane, ethylhexylglycerin,disteardimonium hectorite, silica, allantoin, sodium citrate, 2,3-butanediol, tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEI BELLA DAILY UV DEFENSE  BROAD-SPECTRUM SPF 25 SUNSCREEN
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.225 g  in 74 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.236 g  in 74 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.188 g  in 74 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.094 g  in 74 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.05 g  in 74 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
APPLE (UNII: B423VGH5S9)
DIMETHICONE (UNII: 92RU3N3Y1O)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
2,3-BUTANEDIOL (UNII: 45427ZB5IJ)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PROPANEDIOL (UNII: 5965N8W85T)
GOSSYPIUM HIRSUTUM ROOT (UNII: YGF1E6BVH1)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-403-01	74 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (079711683)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-403)