Label: SPF 30 SUNSCREEN- octinoxate oxybenzone octisalate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 57817-300-01, 57817-300-02, 57817-300-03, 57817-300-04, view more57817-300-05, 57817-300-06, 57817-300-07, 57817-300-08, 57817-300-09, 57817-300-10, 57817-300-11, 57817-300-12, 57817-300-13, 57817-300-14, 57817-300-15, 57817-300-16, 57817-300-17, 57817-300-18, 57817-300-19, 57817-300-20, 57817-300-21, 57817-300-22, 57817-300-23, 57817-300-24, 57817-300-25, 57817-300-26, 57817-300-27, 57817-300-28, 57817-300-29, 57817-300-30, 57817-300-31, 57817-300-32, 57817-300-33, 57817-300-34, 57817-300-35, 57817-300-36, 57817-300-37, 57817-300-38, 57817-300-39, 57817-300-40 - Packager: Hangzhou Haorun Technology CO.,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 March 30, 2013
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- Official Label (Printer Friendly)
- Active Ingredient
- Use
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Warnings
For external use only.Not to be swallowed.Avid contact with eyes.Discontinue use if signs or irritation or rash appear .Use on children under 6 months of age only with advice of a physician.
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Direction
For best results,apply 15-30 minutes befroes sun exposure.Hold bottle 4-6 inches away from body and apply liberally,spraying slowly and evenly until product is visible on skin.Can be applied directly to wet skin.Reapply after swimming,excessive perspiration,towel drying or extended sunexposure .Don not apply in windy conditions.Do not spray into face,Spray into hand and apply to the face.Use in well ventilated areas.
- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 SUNSCREEN
octinoxate oxybenzone octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57817-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Glycerin (UNII: PDC6A3C0OX) Tocopherol (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57817-300-01 10 g in 1 BOTTLE 2 NDC:57817-300-02 12 g in 1 BOTTLE 3 NDC:57817-300-03 15 g in 1 BOTTLE 4 NDC:57817-300-04 20 g in 1 BOTTLE 5 NDC:57817-300-05 25 g in 1 BOTTLE 6 NDC:57817-300-06 30 g in 1 BOTTLE 7 NDC:57817-300-07 35 g in 1 BOTTLE 8 NDC:57817-300-08 40 g in 1 BOTTLE 9 NDC:57817-300-09 45 g in 1 BOTTLE 10 NDC:57817-300-10 50 g in 1 BOTTLE 11 NDC:57817-300-11 60 g in 1 BOTTLE 12 NDC:57817-300-12 70 g in 1 BOTTLE 13 NDC:57817-300-13 80 g in 1 BOTTLE 14 NDC:57817-300-14 90 g in 1 BOTTLE 15 NDC:57817-300-15 100 g in 1 BOTTLE 16 NDC:57817-300-16 110 g in 1 BOTTLE 17 NDC:57817-300-17 120 g in 1 BOTTLE 18 NDC:57817-300-18 150 g in 1 BOTTLE 19 NDC:57817-300-19 180 g in 1 BOTTLE 20 NDC:57817-300-20 200 g in 1 BOTTLE 21 NDC:57817-300-21 250 g in 1 BOTTLE 22 NDC:57817-300-22 300 g in 1 BOTTLE 23 NDC:57817-300-23 2 g in 1 PACKAGE 24 NDC:57817-300-23 2 g in 1 PACKAGE 25 NDC:57817-300-24 3 g in 1 PACKAGE 26 NDC:57817-300-25 4 g in 1 PACKAGE 27 NDC:57817-300-26 5 g in 1 PACKAGE 28 NDC:57817-300-27 6 g in 1 PACKAGE 29 NDC:57817-300-28 7 g in 1 PACKAGE 30 NDC:57817-300-29 8 g in 1 PACKAGE 31 NDC:57817-300-30 9 g in 1 PACKAGE 32 NDC:57817-300-31 10 g in 1 PACKAGE 33 NDC:57817-300-32 12 g in 1 PACKAGE 34 NDC:57817-300-33 15 g in 1 PACKAGE 35 NDC:57817-300-34 20 g in 1 PACKAGE 36 NDC:57817-300-35 25 g in 1 PACKAGE 37 NDC:57817-300-36 30 g in 1 PACKAGE 38 NDC:57817-300-37 35 g in 1 PACKAGE 39 NDC:57817-300-38 40 g in 1 PACKAGE 40 NDC:57817-300-39 45 g in 1 PACKAGE 41 NDC:57817-300-40 50 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/18/2013 Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583) Establishment Name Address ID/FEI Business Operations Hangzhou Haorun Technology CO.,LTD. 421308583 manufacture(57817-300)