Label: DEFENSE ZONE SPORT C/S BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, oxybenzone spray
- NDC Code(s): 13630-0285-4
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 2, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Shake well before use
- Apply liberally 15 minutes before sun exposure and rub into skin
- 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
- 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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Question or comments?
- Defense Zone Sport Broad Spectrum SPF 50 C/S
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INGREDIENTS AND APPEARANCE
DEFENSE ZONE SPORT C/S BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0285 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.15 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength MONOBUTYL MALEATE (UNII: F2LD7FVO1L) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) VINYL ACETATE (UNII: L9MK238N77) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0285-4 146 g in 1 CAN; Type 0: Not a Combination Product 05/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/02/2024 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0285) , analysis(13630-0285) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0285) , label(13630-0285)