Label: INDUSTRIAL STRENGTH SUNSCREEN- zinc oxide, octinoxate, octisalate, and oxybenzone lotion
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NDC Code(s):
59555-102-01,
59555-102-03,
59555-102-04,
59555-102-07, view more59555-102-08, 59555-102-10, 59555-102-11, 59555-102-15, 59555-102-16
- Packager: R & R Lotion, 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 August 5, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure reapply:
- after 80 minutes of swimming or sweating
- immediatly after towel drying
- 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:
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- limit time in the sun, especially from 10am-2pm
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- apply liberally 15 minutes before sun exposure reapply:
- Inactive Ingredients
- Other Information
- Questions & Comments
- PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
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INGREDIENTS AND APPEARANCE
INDUSTRIAL STRENGTH SUNSCREEN
zinc oxide, octinoxate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 64 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 59 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 38 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 47 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Propylene Glycol (UNII: 6DC9Q167V3) Methylparaben (UNII: A2I8C7HI9T) Diethylhexyl Adipate (UNII: MBY1SL921L) Ethylhexyl Palmitate (UNII: 2865993309) Ethylhexyl Stearate (UNII: EG3PA2K3K5) Cetostearyl Alcohol (UNII: 2DMT128M1S) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Diethanolamine Oleth-3 Phosphate (UNII: Y67NX5905E) Glyceryl Monostearate (UNII: 230OU9XXE4) .Alpha.-Tocopherol (UNII: H4N855PNZ1) PEG-100 Stearate (UNII: YD01N1999R) Propylparaben (UNII: Z8IX2SC1OH) Imidurea (UNII: M629807ATL) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-102-03 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/21/2015 2 NDC:59555-102-04 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/21/2015 3 NDC:59555-102-07 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/21/2015 4 NDC:59555-102-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/21/2015 5 NDC:59555-102-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/21/2015 6 NDC:59555-102-11 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/21/2015 7 NDC:59555-102-01 5 mL in 1 PACKET; Type 0: Not a Combination Product 12/21/2015 8 NDC:59555-102-15 4 mL in 1 PACKET; Type 0: Not a Combination Product 12/21/2015 9 NDC:59555-102-16 4 mL in 1 PACKET; Type 0: Not a Combination Product 12/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/21/2015 Labeler - R & R Lotion, Inc (062979000)