Label: MOISTURISING SUNSCREEN SPF 30- homosalate, octisalate, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42315-672-01, 42315-672-02 - Packager: Eshu Pty Ltd
- 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 January 5, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Homosalate 8% Sunscreen
Octisalate 4% Sunscreen
Octinoxate 3% Sunscreen
Octocrylene 2% Sunscreen
Uses
-Helps prevent sunburn
-higher SPF gives more sunburn protection
-provides high protection against sunburn
-for skin highly sensitive to sunburn
-Stop use and ask a doctor if rash or irritation occurs.
-Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk of skin aging, skin cancer, and other harmful effects of the sun
-Does not provide protection for already burnt skin
-every case of sunburn damages the skin permanently
-does not provide 100% protection against UV radiation
-store in a cool dry place
-keep carton. It contains important information
warnings
For external use only
When using this product keep out of eyes. rinse with water to remove
If swallowed, get medical help or call a poison control center right away
Directions
-apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure
-apply enough to give a visible layer before rubbing in .
-re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring.
-Children under 6 years of age: ask a doctor.
Inactive ingredients
Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOISTURISING SUNSCREEN SPF 30
homosalate, octisalate, octinoxate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42315-672 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE (UNII: NMQ347994Z) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) LACTIC ACID (UNII: 33X04XA5AT) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) XANTHAN GUM (UNII: TTV12P4NEE) OLEYL ALCOHOL (UNII: 172F2WN8DV) PANTHENOL (UNII: WV9CM0O67Z) PENTYLENE GLYCOL (UNII: 50C1307PZG) SERINE (UNII: 452VLY9402) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42315-672-02 1 in 1 BOX 1 NDC:42315-672-01 100 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/17/2011 Labeler - Eshu Pty Ltd (753614812) Registrant - Baxter Laboratories Pty. Ltd. (740537709) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 manufacture
