HYDRATING GLOW MIST SPF 50- avobenzone, octisalate, octocrylene spray

HYDRATING GLOW MIST by

Drug Labeling and Warnings

HYDRATING GLOW MIST by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3%

Homosalate 10%

Octilsalate 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 ageing caused by the sun.

WARNINGS

For external use only.

• 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.

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

Butyloctyl Salicylate, D-Alpha-tocopheryl acetate, Ethanol, Fragrance, Hyaluronic acid, Terminalia Ferdinandiana (Kakadu Plum), Citrulius lanatus fruit extract (Watermelon).

OTHER INFORMATION

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

Label

INGREDIENTS AND APPEARANCE

HYDRATING GLOW MIST  SPF 50
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATERMELON (UNII: 231473QB6R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-102-12	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2022
2	NDC: 81104-102-14	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/07/2023
3	NDC: 81104-102-13	75 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/07/2023
4	NDC: 81104-102-11	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2020

Labeler - NAKED SUNDAYS PTY LTD (746918845)