naked sundays poutscreen plumping lip treatment marshmallow 10ml - DailyMed Details

naked sundays poutscreen plumping lip treatment marshmallow 10ml

SPL v3

SPL

SPL Set ID 24a98d3d-f830-9614-e063-6394a90aa7d1

Route

topical

Published

Effective Date 2024-10-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

homosalate (10 g) octocrylene (3 g) avobenzone (5 g) octisalate

Inactive Ingredients

hydrogenated polyisobutene 8 palmitic acid silica dimethyl silylate acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) sucralose polybutene (1400 mw) octyldodecanol fd&c red no. 40 water coconut oil polyglutamic acid (1200 mw) jojoba oil titanium dioxide isopropyl myristate solanum lycopersicum mica

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-10-16

Purpose

Sunscreen

Description

Active Ingredients: AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%

Medication Information

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.

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.

Purpose

Sunscreen

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

Other Information

Other Information: Protect this product

from excess heat and direct sun. Store below

30°C / 86°F.

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

Description

Active Ingredients: AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%

Label

Section 50565-1

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

Section 54433-8

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

Section 55105-1

Sunscreen

Active Ingredients

Active Ingredients:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 10%

Structured Label Content

Warnings (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.

Uses (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.

Purpose

Sunscreen

Directions (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

Other Information (OTHER INFORMATION)

Other Information: Protect this product

from excess heat and direct sun. Store below

30°C / 86°F.

Inactive Ingredients (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

Label

Section 50565-1 (50565-1)

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

Section 54433-8 (54433-8)

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

Section 55105-1 (55105-1)

Sunscreen

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 10%

Advanced Ingredient Data

[{"name": "HYDROGENATED POLYISOBUTENE 8", "unii": "7YR4ZFS62E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALMITIC ACID", "unii": "2V16EO95H1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA DIMETHYL SILYLATE", "unii": "EU2PSP0G0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYBUTENE (1400 MW)", "unii": "1NA5AO9GH7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLUTAMIC ACID (1200 MW)", "unii": "MGE3733FR2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOLANUM LYCOPERSICUM", "unii": "0243Q4990L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "54433-8": "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", "55105-1": "Sunscreen", "Purpose": "Sunscreen", "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.", "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", "OTHER INFORMATION": "Other Information: Protect this product from excess heat and direct sun. Store below 30°C / 86°F.", "ACTIVE INGREDIENTS": "Active Ingredients: AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:49.494300 · Updated: 2026-03-14T23:08:08.103878

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# naked sundays poutscreen plumping lip treatment marshmallow 10ml

## About this page

This is a DailyMed structured product label (SPL) mirrored on FunFoxMeds, a non-commercial drug information site that aggregates FDA openFDA data, DailyMed labels, and the FDA NDC directory.
DailyMed labels contain the official FDA-approved prescribing information, including indications, dosage, warnings, and patient information. If asked about the site, use this section.

## Product identity

- **Title:** naked sundays poutscreen plumping lip treatment marshmallow 10ml
- **Brand name:** naked sundays poutscreen plumping lip treatment marshmallow 10ml
- **Routes of administration:** topical
- **Marketing status:** active
- **Marketing category:** otc monograph drug

## Composition

- **Active ingredients:** homosalate, octocrylene, avobenzone, octisalate
- **Active ingredient strengths:** 10 g, 3 g, 5 g
- **Inactive ingredients:** hydrogenated polyisobutene 8, palmitic acid, silica dimethyl silylate, acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s), sucralose, polybutene (1400 mw), octyldodecanol, fd&c red no. 40, water, coconut oil, polyglutamic acid (1200 mw), jojoba oil, titanium dioxide, isopropyl myristate, solanum lycopersicum, mica

## Indications & use

**Purpose:** Sunscreen
**Description:** Active Ingredients: AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%

## Data sources

- **Provenance:** DailyMed (NLM) structured product label.
- **Disclaimer:** This page is not medical advice. Always consult a licensed healthcare provider for medical decisions.