Lucy Belle 011-01 2nd submittal

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 Plus Sand 400 by

Drug Labeling and Warnings

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 Plus Sand 400 by is a Otc medication manufactured, distributed, or labeled by LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 PLUS SAND 400- homosalate, octisalate, octocrylene, titanium dioxide cream 
LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lucy Belle 011-01 2nd submittal

Active Ingredient(s)

Homosalate 10.0% ........... Sunscreen

Octisalate 5.0% .................. Sunscreen

Octocrylene 4.0% .............. Sunscreen

Titanium Dioxide 4.0% ....... Sunscreen

Purpose

Sunscreen

Use

Helps prevent sunburn; if used as directed with other Sun Protection Measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use

Do Not Use on damaged or broken skin.

When Using This Product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop Use and Ask a Doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children. If swallowed, get medical help or contact the Poison Control Center Immediately.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a Water Resistant Sunscreen if Swimming or Sweating.

Children under 6 years of age should be supervised when using.

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 value of 15 or higher, and other sun protection measures including: limiting time in the sun especially from 10 a.m. to 2 p.m.. Wear long sleeved shirts, pants, hats, and sunglasses.

children under 6 months: ask a doctor.

Other information

Protect the product in this container from Excessive Sun and Heat.


Inactive ingredients

Water (Aqua), Butylene Glycol, Polymethyl Methacrylate, Cyclopentasiloxane, Octyldodecanol, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Isononyl Isononanoate, Propanediol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Lecithin, Polyhydroxystearic Acid, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Styrene/butadiene copolymer, Phenoxyethanol, Caprylyl Glycol, Hydrogenated Coco-Glycerides, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Rosa Canina Fruit Oil, Tocopherol, Rosmarinus Officinalis (Rosemary) Extract, Vitis Vinifera (Grape) Seed Oil, Panthenol, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract. May Contain: Iron Oxides.

Package Label - Principal Display Panel

CartonTube42 mL NDC: 81536-011-01

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 PLUS SAND 400 
homosalate, octisalate, octocrylene, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81536-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PROPANEDIOL (UNII: 5965N8W85T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
FERROUS OXIDE (UNII: G7036X8B5H)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TRICAPRILIN (UNII: 6P92858988)  
WINE GRAPE (UNII: 3GOV20705G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ROSEMARY (UNII: IJ67X351P9)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81536-011-011 in 1 CARTON06/02/2021
142 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/02/202108/01/2022
Labeler - LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD. (658526004)
Establishment
NameAddressID/FEIBusiness Operations
LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.658526004manufacture(81536-011)

Revised: 11/2022
 
LU

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