HYDRATING GLOW MIST SPF 50: Package Insert and Label Information

HYDRATING GLOW MIST SPF 50- avobenzone, homosalate, octisalate and octocrylene spray
NAKED SUNDAYS PTY LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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, Povidone, Silica Silylate, Terminalia Ferdinandiana (Kakadu Plum), Citrulius lanatus fruit extract (Watermelon).

OTHER INFORMATION

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

Label

label
(click image for full-size original)

HYDRATING GLOW MIST SPF 50
avobenzone, octisalate, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-102(NDC:30807-1007)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLOCTYL SALICYLATE
.ALPHA.-TOCOPHEROL ACETATE
ALCOHOL
HYALURONIC ACID
POVIDONE
SILICA DIMETHYL SILYLATE
KAKADU PLUM
WATERMELON
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81104-102-11 100 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2020
Labeler — NAKED SUNDAYS PTY LTD (746918845)

Revised: 09/2021 NAKED SUNDAYS PTY LTD

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