BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN by

Drug Labeling and Warnings

BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN 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
• Higher SPF gives more sunburn protection
• 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.
• Retains SPF after 80 minutes of activity in the water.

Warnings

For external use only

Do not use

on damaged or broken skin.

Keep out of reach of children.

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash or irritation develops and lasts.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply:
• after 80 minutes of swimming or sweating
• 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.

Other information

• Protect the product in this container from excessive heat and direct sun.
• You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.

Inactive Ingredients

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

Questions?

888-266-0772 or visit bondisands.com

Company Information

Made in Australia.

Distributed by Bondi Sands USA

Wilmington, DE 19808

bondisands.com

Product Packaging

bondi sands

The Australian tan

BROAD SPECTRUM

HYDRA

UV PROTECT

SPF 70

SUNSCREEN LOTION

VERY WATER RESISTANT 80 MINUTES

PLANT BASED HYDRATION

REEF FRIENDLY

Australian Made

5.07 FL. OZ. (150mL)

INGREDIENTS AND APPEARANCE

BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79950-012
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARRAGEENAN (UNII: 5C69YCD2YJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79950-012-01	150 mL in 1 TUBE; Type 0: Not a Combination Product	08/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/05/2021

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