CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50- avobenzone, homosalate octisalate, octocrylene cream

CLEAR GLOW BROAD SPECTRUM SUNCREEN by

Drug Labeling and Warnings

CLEAR GLOW BROAD SPECTRUM SUNCREEN by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD, WILD CHILD LABORATORIES 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

Warnings: For external use only. Do not use on
damaged or broken skin. Avoid prolonged sun
exposure. If it gets in your eyes, wash well with
water. Keep out of reach of children. Stop use
and ask a doctor if rashes occur. If product is
swallowed, get medical help or contact a Poison
Control Center right away.

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

Inactive Ingredients: Medium Chain
Triglycerides, Ceresin, Dicaprylyl Carbonate,
Butyloctyl Salicylate, Polyethylene, Citrillus Lanatus

OTHER INFORMATION

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

USER SAFETY WARNINGS

Directions: Apply generously 15 minutes before
sun exposure. Use a water-resistant sunscreen if
swimming or sweating. Reapply immediately after
towel drying. Reapply at least every 2 hours.
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 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor.

Label

INGREDIENTS AND APPEARANCE

CLEAR GLOW BROAD SPECTRUM SUNCREEN  SPF 50
avobenzone, homosalate octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-984
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TOMATO JUICE (UNII: U4475AYH9C)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-984-11	19 g in 1 CONTAINER; Type 0: Not a Combination Product	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/30/2023

Labeler - NAKED SUNDAYS PTY LTD (746918845)

Establishment
Name	Address	ID/FEI	Business Operations
WILD CHILD LABORATORIES PTY LTD		890661643	manufacture(81104-984)