LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 55- Fair 130 by LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD. Lucy Belle 001-01

Drug Details [pdf]

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 55- 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.

----------

Lucy Belle 001-01

Active Ingredient(s)

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 4.0 %

Titanium Dioxide 4.0 %

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

on damaged or broken skin.

keep out of eyes, and mouth. In case of contact with eyes, rinse thoroughly with water.

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 SPF of 15 or higher and other sun protection measures including: limiting time in the sun, especially from 10 a.m. - 2 p.m. Wear long sleeve 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, 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, Vitas Vinitera (Grape) Seed Oil, Panthenol, Niacinamide, Cucumis sativus (Cucumber) Fruit Extract, May Contain,: Iron Oxides.

Package Label - Principal Display Panel

Tube Carton 42 mL NDC: 81536-001-01

LAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 55- FAIR 130
homosalate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81536-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
OCTYLDODECANOL (UNII: 461N1O614Y)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
FERROUS OXIDE (UNII: G7036X8B5H)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
WINE GRAPE (UNII: 3GOV20705G)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 81536-001-01	1 in 1 CARTON	02/22/2021
1		42 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/22/2021	05/25/2021

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

Name	Address	ID/FEI	Business Operations
Establishment
LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.		658526004	manufacture(81536-001)

Revised: 5/2021

Document Id: c3338fcc-e560-7ede-e053-2a95a90ae6d1

Set id: bbf9b28a-8593-30a8-e053-2995a90a5e77

Version: 2

Effective Time: 20210525