BROAD SPECTRUM SPF50 SPF 50- avobenzone, homosalate octisalate, gel

BROAD SPECTRUM SPF50 by

Drug Labeling and Warnings

BROAD SPECTRUM SPF50 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%

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.
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. 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. Use a
water-resistant sunscreen if swimming
or sweating.

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:
Water, Butyloctyl Salicylate,
Propylene Glycol, Acrylates
Copolymer, Euphorbia Cerifera
(Candelilla) Wax, Phenoxyethanol,
Hydroxyacetophenone,
Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Glycerin, Tocopheryl
Acetate, Polyacrylate
Crosspolymer-6, Ethylhexylglycerin,
Sodium Hyaluronate, Sodium
Hydroxide, Terminalia Ferdinandiana
(Kakadu Plum) Fruit Extract,
Disodium EDTA, Citric Acid

OTHER INFORMATION

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

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.

WARNINGS AND PRECAUTIONS

Directions:
Apply generously 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 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 10AM - 2PM
Wear long-sleeved shirts, pants,
hats, and sunglasses

Label

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF50  SPF 50
avobenzone, homosalate octisalate, gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-801
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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-801-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/30/2023
2	NDC: 81104-801-02	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2024

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)