Label: LEADER GENERAL PROTECTION SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 37205-728-34
- Packager: Cardinal Health
- 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 October 3, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- Keep out of reach of children.
-
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
- 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
water, sorbitan isostearate, sorbitol, triethanolamine, polyglyceryl-3 distearate, stearic acid, octadecene/MA copolymer, barium sulfate, benzyl alcohol, VP/eicosene copolymer, dimethicone, carbomer, methylparaben, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, tocopherol (vitamin E), cocos nucifera (coconut) oil, mineral oil, propylparaben, fragrance, disodium EDTA
- Other infomation
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER GENERAL PROTECTION SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-728 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 105 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength MALEIC ACID (UNII: 91XW058U2C) WATER (UNII: 059QF0KO0R) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITOL (UNII: 506T60A25R) TROLAMINE (UNII: 9O3K93S3TK) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) STEARIC ACID (UNII: 4ELV7Z65AP) OCTADECENE (UNII: H5ZUQ6V4AK) BARIUM SULFATE (UNII: 25BB7EKE2E) BENZYL ALCOHOL (UNII: LKG8494WBH) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) DIMETHICONE (UNII: 92RU3N3Y1O) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) METHYLPARABEN (UNII: A2I8C7HI9T) ALOE VERA LEAF (UNII: ZY81Z83H0X) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) MINERAL OIL (UNII: T5L8T28FGP) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-728-34 237 mL in 1 CAN; Type 0: Not a Combination Product 01/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/15/2012 Labeler - Cardinal Health (097537435)
