SPF 55 by AS Beauty / Shanghai Elegance Cosmetics Co., Ltd.

SPF 55 by

Drug Labeling and Warnings

SPF 55 by is a Otc medication manufactured, distributed, or labeled by AS Beauty, Shanghai Elegance Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 55- 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

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 55 
homosalate, octisalate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74884-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STYRENE (UNII: 44LJ2U959V)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIMETHICONE 100 (UNII: RO266O364U)
1,3-BUTADIENE (UNII: JSD5FGP5VD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
ALTEROMONAS MACLEODII (UNII: BPX036043D)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PANTHENOL (UNII: WV9CM0O67Z)
PROPANEDIOL (UNII: 5965N8W85T)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CUCUMBER (UNII: YY7C30VXJT)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
XYLOSE (UNII: A1TA934AKO)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: 74884-259-06	30 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2021	05/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2021	05/15/2021

Labeler - AS Beauty (116977536)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Elegance Cosmetics Co., Ltd.		539966125	manufacture(74884-259)

Revised: 8/2022

Document Id: e58111fa-7c57-62e0-e053-2995a90a3bfa

34390-5

Set id: ba726c8a-bfc0-11f7-e053-2995a90a239e

Version: 6

Effective Time: 20220805