Label: SUNSCREEN- oxybenzone,octinoxate,octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71011-004-01 - Packager: NingBo Huize Commodity 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 July 18, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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WARNINGS:
Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs
- Keep out of reach of children.
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN
oxybenzone,octinoxate,octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71011-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) DMDM HYDANTOIN (UNII: BYR0546TOW) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) HEXADECANAL (UNII: WQD27655QE) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71011-004-01 100 in 1 BOX 07/18/2018 1 30 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/18/2018 Labeler - NingBo Huize Commodity Co.,Ltd. (544434795) Registrant - NingBo Huize Commodity Co.,Ltd. (544434795) Establishment Name Address ID/FEI Business Operations NingBo Huize Commodity Co.,Ltd. 544434795 manufacture(71011-004)