HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50- homosalate, octocrylene, octisalate, avobenzone cream

Hydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50 by

Drug Labeling and Warnings

Hydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50 by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Homosalate 10% .............Sunscreen

Octocrylene 8% ...............Sunscreen

Octisalate 5% ..................Sunscreen

Avobenzone 3% ..............Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

• For external use only
• Do not use on damaged or broken skin
• When using this product, keep out of eyes. RInse with water to remove.
• If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 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 10a.m.-2p.m.
• wear long sleeve shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Water, Beeswax, Isopropryl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinensis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric Acid

OTHER SAFETY INFORMATION

Other informaiton Protect the product in this container from excessive heat and direct sun

Questions or comments?
Contact us at frankbody.com

PRINCIPAL DISPLAY PANEL

frank body

SPF 50+

Hydrating Body Sunscreen

UVA + UVB Broad Spectrum SPF50+

With hyaluronic acid

Fast absorbing

Water resistant (80 minutes)

4.73fl oz - 140ml

INGREDIENTS AND APPEARANCE

HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50 
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-009-01	140 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	12/01/2022

Labeler - Baxter Laboratories Pty. Ltd. (740537709)