SPF 50 plus by AS Beauty / LUCY BELLE BIOLOGICAL TECHNOLOGY CO.,LTD

SPF 50 plus by

Drug Labeling and Warnings

SPF 50 plus by is a Otc medication manufactured, distributed, or labeled by AS Beauty, LUCY BELLE BIOLOGICAL TECHNOLOGY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 50 PLUS- homosalate, octisalate, octocrylene, and titanium dioxide cream 
AS Beauty

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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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: Limit Time in the sun especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses.

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

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 dotor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach of Children

Sunscreen

Sunscreen

For External Use Only.

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

SPF 50 PLUS 
homosalate, octisalate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74884-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DIMETHICONE 100 (UNII: RO266O364U)
1,3-BUTADIENE (UNII: JSD5FGP5VD)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
ALTEROMONAS MACLEODII (UNII: BPX036043D)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
STYRENE (UNII: 44LJ2U959V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CUCUMBER (UNII: YY7C30VXJT)
XYLOSE (UNII: A1TA934AKO)
PANTHENOL (UNII: WV9CM0O67Z)
PROPANEDIOL (UNII: 5965N8W85T)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ROSEMARY (UNII: IJ67X351P9)
WATER (UNII: 059QF0KO0R)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Product Characteristics
Color		Score
Shape	RECTANGLE (Plastic Tube)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74884-164-01	30 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/15/2021	08/01/2022

Labeler - AS Beauty (116977536)

Establishment
Name	Address	ID/FEI	Business Operations
LUCY BELLE BIOLOGICAL TECHNOLOGY CO.,LTD		658526004	manufacture(74884-164)

Revised: 12/2022

Document Id: efa7646f-8c5b-7b57-e053-2a95a90a1f71

34390-5

Set id: ba72a7a0-66cf-0cd1-e053-2a95a90a008d

Version: 15

Effective Time: 20221212