Naked Sundays Hydrating Glow Mist Spf 50

Naked Sundays Hydrating Glow Mist Spf 50
SPL v10
SPL
SPL Set ID dca2f4ce-1a3a-707e-e053-2995a90abad7
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (8 g)
Inactive Ingredients
Butyloctyl Salicylate .alpha.-tocopherol Acetate Alcohol Hyaluronic Acid Kakadu Plum Watermelon

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-12-01 Until 2025-11-14

Description

Avobenzone 3% Homosalate 10% Octilsalate 5% Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octilsalate 5% Octocrylene 8%

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.

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.

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.
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

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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Octocrylene 8%

Inactive Ingredients

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


Structured Label Content

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.

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.

Purpose

Sunscreen

Warnings (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.
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)

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

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Octocrylene 8%

Inactive Ingredients (INACTIVE INGREDIENTS)

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


Advanced Ingredient Data


Raw Label Data

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