HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50- avobenzone, homosalate octisalate, cream

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 by

Drug Labeling and Warnings

HYDRATING SUNSCREEN MOISTURIZER 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

Use:
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, Ethylhexyl
Methoxycrylene, Dimethicone, Potassium
Cetyl Phosphate, Glyceryl Stearate, Sodium
Polyacrylate, Niacinamide, Tocopheryl
Acetate, Hydroxyacetophenone, Sodium
Benzoate, Glyceryl Caprylate, Sodium
Hyaluronate, Disodium EDTA, Citric Acid,
Sodium Hydroxide

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.

INDICATIONS & USAGE

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

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50  SPF 50
avobenzone, homosalate octisalate, cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-802
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)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-802-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/30/2023

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)