DAILY DEFENCE MOISTURISING SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 3.0% w/w Sunscreen

Homosalate 8.0% w/w Sunscreen

Octisalate 5.0% w/w Sunscreen

Octocrylene 7.0% w/w Sunscreen

PURPOSE

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and earlt skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Contol Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if

• rash occurs

WARNINGS

Warnings

Do not use

• On damaged or broken skin

When using this product

• Keep out of eyes. Rinse with water to remove

For External use only

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Children under 6 months of age: ask a doctor
• Sun Protection Measures. Spending time int 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 a.m. – 2 p.m.

Wear long-sleeved shirts, pants hats, and sunglasses.

• reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

Inactive ingredients: Water/Aqua, Propanediol, Niacinamide, Methylpropanediol, Potassium Cetyl Phosphate, Microcrystalline Cellulose, Silica, Poly C10-30 Alkyl Acrylate, Cellulose, Caprylyl Methicone, Polysilicone-15, Stearyl Alcohol, Cetyl Alcohol, Caprylyl Glycol,Glycerin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Panthenol, Carbomer, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Hibiscus Sabdariffa Fruit Extract, Hyaluronic Acid, Phenylpropanol.

OTHER SAFETY INFORMATION

Other information

Protect from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Daily Defense Moisturising Sunscreen SPF 50

Broad Spectrum Protection

75 mL/ 2.54 fl. oz.

INGREDIENTS AND APPEARANCE

DAILY DEFENCE MOISTURISING SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GRAPEFRUIT OIL (UNII: YR377U58W9)
PHENYLPROPANOL (UNII: 0F897O3O4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CETYL ALCOHOL (UNII: 936JST6JCN)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
ERYTHRITOL (UNII: RA96B954X6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSILICONE-15 (UNII: F8DRP5BB29)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
LEVOMENOL (UNII: 24WE03BX2T)
HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y)
CARNOSINE (UNII: 8HO6PVN24W)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
PROPANEDIOL (UNII: 5965N8W85T)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-053-02	1 in 1 CARTON	04/29/2026
1	NDC: 10028-053-01	75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/29/2026

Labeler - Ultraceuticals Pty Ltd (744068995)