Label: CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 70000-0075-1
- 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 and evenly 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
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Inactive ingredients
water, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance
- Label
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INGREDIENTS AND APPEARANCE
CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0075 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SORBITOL (UNII: 506T60A25R) TROLAMINE (UNII: 9O3K93S3TK) POLYETHYLOXAZOLINE (5000 MW) (UNII: HNX7574GTX) DIMETHICONE (UNII: 92RU3N3Y1O) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) BENZYL ALCOHOL (UNII: LKG8494WBH) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0075-1 237 g in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/10/2020 Labeler - CARDINAL HEALTH, INC. (063997360)
