Label: NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT MARSHMALLOW 10ML- lip treatment liquid
- NDC Code(s): 81104-249-01
- Packager: NAKED SUNDAYS PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
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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
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INACTIVE INGREDIENTS
Polybutene, Isopropyl Myristate, Octyldodecanol, Poly C10-30
Alkyl Acrylate, Silica Silylate Flavor, Cocos Nucifera
(Coconut) Oil,Mica,Hydrogenated Polyisobutene,Palmitic Acid , Titanium Dioxide (Cl 77891), Simmondsia Chinensis (Jojoba) Seed Oil, Solanum Lycopersicum
(Tomato) Fruit Extract, Titanium Dioxide (CI 77891).
Red 40 (Cl 16035) Polyglutamic Acid Water, Sucralose - OTHER INFORMATION
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USER SAFETY WARNINGS
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 - PURPOSE
- Label
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INGREDIENTS AND APPEARANCE
NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT MARSHMALLOW 10ML
lip treatment liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-249 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 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E) PALMITIC ACID (UNII: 2V16EO95H1) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) SUCRALOSE (UNII: 96K6UQ3ZD4) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) OCTYLDODECANOL (UNII: 461N1O614Y) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2) JOJOBA OIL (UNII: 724GKU717M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-249-01 10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 10/16/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/16/2024 Labeler - NAKED SUNDAYS PTY LTD (746918845)
