Naked Sundays Broad Spectrum SPF 50+ Hydrating Glow Mist

Naked Sundays by

Drug Labeling and Warnings

Naked Sundays by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAKED SUNDAYS SPF 50 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Enterprises

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Naked Sundays Broad Spectrum SPF 50+ Hydrating Glow Mist

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Purpose

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 external use only
• Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging
• Flammable: Keep away from flames and sparks. Wait 5/10 minutes after application before approaching a source of heat or flame, or before smoking.

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

• avoid eye area
• shake well before use
• use as top up sunscreen only
• hold 8-10" away from your body and spray liberally & evenly until skin feels moist 15 minutes before sun exposure. Do not spray directly on to face. Make sure no spots are missed by spraying onto hands and applying to face
• Do not apply in windy conditions
• Use in well-ventlated area
• Avoid inhalation
• Use a water resistant sunscreen if swimming or sweating
• Reapply immediately after towel drying
• Reapply at least every 2 hours
• 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 10 am to 2 pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Ethanol, Citrullus Lanatus Seed Oil, Hyaluronic Acid, Kakadu Plum, Tocopheryl Acetate, Fragrance

Other Information

Protect the product in this container from excessive heat and direct sun

Naked Sundays Hydrating Glow Mist Broad Spectrum SPF 50+

NAKED SUNDAYS  SPF 50 BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0661
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	69.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.1 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	87 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATERMELON SEED OIL (UNII: L33J06UQTT)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
ALCOHOL (UNII: 3K9958V90M)
HYALURONIC ACID (UNII: S270N0TRQY)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	yellow (Light Yellow to Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0661-3	75 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/31/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(58443-0661) , label(58443-0661) , manufacture(58443-0661) , pack(58443-0661)

Revised: 7/2024

Document Id: 1e8fdb0f-f6c9-45e9-e063-6294a90a4619

34390-5

Set id: 1e8fdb0f-f6c8-45e9-e063-6294a90a4619

Version: 1

Effective Time: 20240731