BONDI SANDS SPF 60 SUNNY FACE- avobenzone, homosalate, octisalate, octocrylene lotion

Bondi Sands SPF 60 Sunny Face by

Drug Labeling and Warnings

Bondi Sands SPF 60 Sunny Face by is a Otc medication manufactured, distributed, or labeled by BONDI SANDS (USA) INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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 aging caused by the sun.

Warnings

• For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. If eye contact occurs, rinse thoroughly with clean running water.

Stop use and ask a doctor

if rash or irritation occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well before use.
• Apply liberally and evenly 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply:
• immediately after towel drying.
• 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 10 a.m. – 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Other Information

• Protect the product in this container from excessive heat and direct sun.
• You may report a serious adverse reaction to 888-339-7642; Monday – Friday, 9 am – 5 pm.

Inactive Ingredients

Water/Aqua/Eau, Beeswax, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, Isopropyl Palmitate, Ceteareth-20, Hibiscus Sabdariffa Fruit Extract, Cyclohexasiloxane, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Stearoyl Glutamate, Aminomethyl Propanediol, Tocopheryl Acetate, Sodium Carrageenan, Sodium Chloride.

Questions?

888-339-7642 or visit bondisands.com

Product Labeling

INGREDIENTS AND APPEARANCE

BONDI SANDS SPF 60 SUNNY FACE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79950-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
BEESWAX (UNII: 2ZA36H0S2V)
CETEARETH-20 (UNII: YRC528SWUY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SODIUM CARRAGEENAN (UNII: 7CY8BVL34N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79950-019-01	1 in 1 CARTON	01/08/2025
1		50 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	01/08/2025

Labeler - BONDI SANDS (USA) INC. (117596864)