Label: CARDINAL HEALTH LEADER SPF 50 GENERAL PROTECTION SUNSCREEN- avobenzone,homosalate, octisalate, octocrylene, oxybenzone. lotion
- NDC Code(s): 70000-0408-1
- Packager: CARDINAL HEALTH, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 4, 2022
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- 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
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: Ask a doctor
• 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 - Other information
- Inactive Ingredients
- Label
-
INGREDIENTS AND APPEARANCE
CARDINAL HEALTH LEADER SPF 50 GENERAL PROTECTION SUNSCREEN
avobenzone,homosalate, octisalate, octocrylene, oxybenzone. lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0408 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 130 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) BENZYL ALCOHOL (UNII: LKG8494WBH) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) TOCOPHEROL (UNII: R0ZB2556P8) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0408-1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2019 Labeler - CARDINAL HEALTH, INC. (063997360)
