Lucy Belle 006-01 2nd submittal

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 Plus Fair 130 by

Drug Labeling and Warnings

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 Plus Fair 130 by is a Otc medication manufactured, distributed, or labeled by LUCY BELLE BIOLOGICAL TECHNOLOGY CO.,LTD, 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 FAIR 130- 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 006-01 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 the Poison Control Center Immediately.

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, , 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

42 mL NDC: 81536-006-01

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 PLUS FAIR 130 
homosalate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81536-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRICAPRILIN (UNII: 6P92858988)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
WINE GRAPE (UNII: 3GOV20705G)
OCTYLDODECANOL (UNII: 461N1O614Y)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81536-006-01	1 in 1 CARTON	05/24/2021
1		42 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 final	part352	05/24/2021	08/01/2022

Labeler - LUCY BELLE BIOLOGICAL TECHNOLOGY CO.,LTD (658526004)

Establishment
Name	Address	ID/FEI	Business Operations
LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.		658526004	manufacture(81536-006)

Revised: 11/2022

Document Id: eeb805d0-2561-4784-e053-2a95a90ad2c7

34390-5

Set id: c32debcb-b2c6-1a0f-e053-2a95a90aa776

Version: 5

Effective Time: 20221130