Label: HYDRATING BODY SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone lotion
- NDC Code(s): 82975-101-01
- Packager: frank body
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 31, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
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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
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Directions
•Apply generously and evenly 15 minutes before sun exposure•Reapply: After 80 minutes of swimming or swweating.• Immediately after towel drying.• At leaset 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
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Inactive ingredients
Water, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinesis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric acid
- Other informaiton
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
frank body
SPF 50+
HYDRATING BODY SUNSCREEN
UVA + UVB Broad Spectrum SPF 50+
With hyaluronic acid
Fast absorbing
Water resistant (80 minutes)
4.73 fl oz - 140 ml
Distributed by frank body: 33 Cremorne Street
Cremorne VIC 3121 Australia / frank body, LLC:
1145 Broadway, Floor 4 New York, NY 10001, USA
Made in Australia
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INGREDIENTS AND APPEARANCE
HYDRATING BODY SUNSCREEN
homosalate, octocrylene, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82975-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) KAKADU PLUM (UNII: 0ZQ1D2FDLI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) RUBUS IDAEUS SEED (UNII: M3CL7US2ZG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) JOJOBA OIL (UNII: 724GKU717M) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) BENZYL ALCOHOL (UNII: LKG8494WBH) MALTODEXTRIN (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82975-101-01 140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/31/2022 Labeler - frank body (747810740)