Attitude Sunly Lip Balm - Coconut - Spf 15

Attitude Sunly Lip Balm - Coconut - Spf 15
SPL v5
SPL
SPL Set ID 068af2ec-a666-45bf-b0e0-89d1b93dedf1
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g)
Inactive Ingredients
Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Trihydroxystearin Behenyl Behenate Glyceryl Monobehenate Octyldodecanol Coconut Oil Polyhydroxystearic Acid (2300 Mw) Shea Butter Sunflower Oil Helianthus Annuus Seed Wax Medium-chain Triglycerides Castor Oil Argan Oil Candelilla Wax Vanillin .gamma.-octalactone .gamma.-nonalactone Ethyl Caproate Ethyl Acetate Manganese Violet Jojoba Oil, Randomized Stearoyl Glutamic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-15

Description

DRUG FACTS

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

Uses

Helps prevent sunburn.

Section 42229-5

DRUG FACTS

Section 43683-2

Update of the directions

Section 50565-1

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

Section 50566-9

Stop use and consult a doctor if rash occurs.

Section 50570-1

Do not use on broken skin.

Section 53413-1

Questions ? 1-855-509-7225

Warnings

For external use only.

Directions

Adults and children older than 6 months.

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours, after eating or drinking.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
  • Use a water resistant sunscreen if swimming or sweating.
Other Information

Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.

Medicinal Ingredient

Zinc oxide (10%)

Inactive Or Non Medicinal Ingredients

Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic Acid, Ethyl Acetate*, Ethyl Hexanoate*, Gamma-Nonalactone*, Gamma-Octalactone*, Vanillin*, *flavour (Aroma).

Principal Display Panel 8.5 G Tube Carton

ATTITUDE

natural care

SPF 15

coconut

lip balm

universal shade

BROAD SPECTRUM SUNSCREEN SPF 15

UVA UVB + NON NANO

SUNLY

8.5 g / 0.3 oz.

NPN 80109103

Vegan

EWG Verified

Ocean Lovers

Dermatologically tested


Structured Label Content

Uses

Helps prevent sunburn.

Section 42229-5 (42229-5)

DRUG FACTS

Section 43683-2 (43683-2)

Update of the directions

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and consult a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on broken skin.

Section 53413-1 (53413-1)

Questions ? 1-855-509-7225

Purpose

Sunscreen

Warnings

For external use only.

Directions

Adults and children older than 6 months.

  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours, after eating or drinking.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
  • Use a water resistant sunscreen if swimming or sweating.
Other Information

Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.

Medicinal Ingredient (Medicinal ingredient)

Zinc oxide (10%)

Inactive Or Non Medicinal Ingredients (Inactive or non-medicinal ingredients)

Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic Acid, Ethyl Acetate*, Ethyl Hexanoate*, Gamma-Nonalactone*, Gamma-Octalactone*, Vanillin*, *flavour (Aroma).

Principal Display Panel 8.5 G Tube Carton (PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton)

ATTITUDE

natural care

SPF 15

coconut

lip balm

universal shade

BROAD SPECTRUM SUNSCREEN SPF 15

UVA UVB + NON NANO

SUNLY

8.5 g / 0.3 oz.

NPN 80109103

Vegan

EWG Verified

Ocean Lovers

Dermatologically tested


Advanced Ingredient Data


Raw Label Data

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