Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL

Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL by

Drug Labeling and Warnings

Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL by is a Otc medication manufactured, distributed, or labeled by Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT CARAMEL LATTE 10ML- lip treatment liquid 
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho

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Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL

ACTIVE INGREDIENTS

Active Ingredients:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 10%

Purpose

Sunscreen

USES

Uses: Helps prevent sunburn. If used as
directed with other sun protection measures
(see directions), decreases the risk of skin
cancer and early skin ageing caused by the sun.

WARNINGS

Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
If product is swallowed, get medical help or
contact a Poison Control Center right away.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Reapply at least every 2 hours.
  • Children under 3 years of age: Ask a doctor.

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 value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10.00AM - 2.00PM
  • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

Polybutene, Isopropyl Myristate, Octyldodecanol, Poly C10-30
Alkyl Acrylate, Silica Silylate, Flavor, Cocos Nucifera
(Coconut) Oil, Mica (Cl 77019), Iron Oxide (Cl 77491), Titanium Dioxide (Cl 77891), Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Solanum Lycopersicum
(Tomato) Fruit Extract, Mica (Cl
77019), Titanium Dioxide (CI 77891).
Iron Oxide (Cl 77491), Carmine (CI 75470),
Polyglutamic Acid Water, Sucralose

OTHER INFORMATION

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

Directions: "Apply generously 15 minutes before sun exposure. Reapply at least every 80 minutes or immediately after swimming, sweating or towel drying. Use a water- resistant sunscreen if swimming
or sweating. "Children under 6' months of age: Ask a Doctor


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 value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and sunglasses

Sunscreen

Label

1

NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT CARAMEL LATTE 10ML 
lip treatment liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62282-247
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
COCONUT OIL (UNII: Q9L0O73W7L)  
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)  
SQUALANE (UNII: GW89575KF9)  
MICA (UNII: V8A1AW0880)  
JOJOBA OIL (UNII: 724GKU717M)  
CARMINIC ACID (UNII: CID8Z8N95N)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62282-247-0110 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product10/16/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/16/2024
Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)

Revised: 10/2024
 
Northwest Cosmetic Lab

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