Label: AVOBENZONE, HOMOSALATE, OCTISALATE spray
- NDC Code(s): 75712-949-14
- Packager: Old East Main Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Flammable
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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
■ children under 6 months of age: Ask a doctor - Other information
- Inactive ingredients
- Claims
- Adverse Reaction
- Principal display panel
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INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE
avobenzone, homosalate, octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75712-949 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 120 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75712-949-14 156 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/25/2023 Labeler - Old East Main Co. (006946172) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(75712-949)
