Label: SPORT- avobenzone, homosalate, octisalate, octisalate spray
- NDC Code(s): 11822-0085-1
- Packager: Rite Aid
- 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 September 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- 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
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SPL UNCLASSIFIED SECTION
May stain or damage some fabrics or surfaces
*This product is not manufactured or distributed by Edgwell Personal
Care, distributer of Banana Boat Sport Performance CollZone Clear
Sunscreen Spray UVA/UBV Broad Spectrum SPF 50+.
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 170411
www.riteaid.com
SATISFACTION GUARANTEE:
If you're not satisfied, we'll happily refund your money.
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INGREDIENTS AND APPEARANCE
SPORT
avobenzone, homosalate, octisalate, octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3 g in 1 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 2250 g in 1 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 250 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) stearoxytrimethylsilane (UNII: 9862TW94B2) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) TOCOPHEROL (UNII: R0ZB2556P8) butyloctyl salicylate (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0085-1 156 g in 1 CAN; Type 0: Not a Combination Product 12/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/02/2021 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-0085) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-0085)