CLARITY RX PUCKER POWER LIP PLUMPER SPF 30- homosalate, octinoxate, octisalate, avobenzone lipstick

Clarity Rx Pucker Power lip plumper by

Drug Labeling and Warnings

Clarity Rx Pucker Power lip plumper by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 15.0%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octisalate 5.0%	Sunscreen
Avobenzone 3.0%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For lip application only.

This product delivers a temporary tingling sensation to the lips. Only apply product inside the line of your lips.

When using this product keep out of eyes, rinse with water to remove.

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Apply a generous coat to bare lips as often as desired, staying inside the lip line. Visible volume and natural color typically lasts 1-2 hours. Individual results may vary.

• 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 sunscreen measures including:
  • limit time in the sun, especially from 10a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Hydrogenated Polyisobutene, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Octocrylene, Benzyl Nicotinate, Glycerin, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Portulaca Pilosa Extract, Sucrose Cocoate, Palmitoyl Tripeptide-38, Sodium Hyaluronate, Menthone Glycerin Acetal, Stevia Rebaudiana Leaf/Stem Powder, Niacinamide, Tocopheryl Acetate, Hydrolyzed Sodium Hyaluronate, Glutathione, Ergothioneine, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Yucca Schidigera Root Extract, Salix Alba (Willow) Bark Extract, Panthenol, Essential Oil of Spearmint (Mentha Viridis), Essential Oil of Peppermint (Mentha Piperita), Flavor.

PRINCIPAL DISPLAY PANEL - 4 ml Tube Box

CLARITY RX®

PUCKER POWER™

3-in-1 Plumping Lip Treatment

Broad Spectrum SPF 30 Sunscreen

Net 0.14 fl. oz. / 4ml

INGREDIENTS AND APPEARANCE

CLARITY RX PUCKER POWER LIP PLUMPER  SPF 30
homosalate, octinoxate, octisalate, avobenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTOCRYLENE (UNII: 5A68WGF6WM)
BENZYL NICOTINATE (UNII: S497LCF9C9)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLUTATHIONE (UNII: GAN16C9B8O)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)
SALIX ALBA BARK (UNII: 205MXS71H7)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
NIACINAMIDE (UNII: 25X51I8RD4)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SPEARMINT OIL (UNII: C3M81465G5)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
PEPPERMINT OIL (UNII: AV092KU4JH)
PALMITOYL TRIPEPTIDE-38 (UNII: T7A529FB8O)
CHOLESTEROL (UNII: 97C5T2UQ7J)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-001-01	1 in 1 BOX	10/16/2020
1		10 g 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 DRUG	M020	10/16/2020

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-001)