Label: NEUTROGENA SPORT ACTIVE DEFENSE SPF 30- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 69968-0824-5
- Packager: Johnson & Johnson Consumer Inc.
- 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 15, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold container 4-6 inches from the skin to apply. Rub in.
• do not spray directly into face. Spray on hands and then apply to face. Rub in.
• 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 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
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 141 g Can Label
NEW
Neutrogena ®
DERMATOLOGIST RECOMMENDED BRAND
Sport
active defense
sunscreen
30
BROAD SPECTRUM SPF 30
skin barrier protection
helioplex ®
broad spectrum uva●uvb
ANTIOXIDANTS
VITAMINS C & E
SWEAT + SUN + H2O DEFENSE
protects & refreshes
non-sticky ● quick-drying
water resistant (80 minutes)
NET WT 5.0 OZ (141 g)
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INGREDIENTS AND APPEARANCE
NEUTROGENA SPORT ACTIVE DEFENSE SPF 30
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0824 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 80 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE (UNII: QN83US2B0N) ALCOHOL (UNII: 3K9958V90M) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ISOBUTANE (UNII: BXR49TP611) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0824-5 141 g in 1 CAN; Type 0: Not a Combination Product 12/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/04/2023 Labeler - Johnson & Johnson Consumer Inc. (118772437)