Label: EXTREME PROTECT SPF 30- octinoxate, zinc oxide lotion
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NDC Code(s):
69219-103-13,
69219-103-15,
69219-103-28,
69219-103-51, view more69219-103-55, 69219-103-58
- Packager: SCIENCE OF SKINCARE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• Use a water resistant sunscreen if swimming or sweating
• Reapply 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:
o limit time in the sun, especially from 10 a.m.-2 p.m.
o wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor - Other Information
- Questions or Comments?
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Inactive Ingredients
Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
EXTREME PROTECT SPF 30
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69219-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4.12 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYL PALMITATE (UNII: 2865993309) PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCOL STEARATE SE (UNII: 6YLY96TQL6) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) ALOE VERA LEAF (UNII: ZY81Z83H0X) ASIATICOSIDE (UNII: PKO39VY215) ASIATIC ACID (UNII: 9PA5A687X5) MADECASSIC ACID (UNII: M7O1N24J82) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) OLEYL ALCOHOL (UNII: 172F2WN8DV) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PEG-100 STEARATE (UNII: YD01N1999R) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69219-103-51 1 in 1 BOX 10/01/2014 1 NDC:69219-103-13 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:69219-103-55 1 in 1 BOX 10/01/2014 2 NDC:69219-103-15 5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:69219-103-28 240 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2014 4 NDC:69219-103-13 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2014 5 NDC:69219-103-15 5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2014 6 NDC:69219-103-58 1 in 1 BOX 08/01/2023 6 240 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2014 Labeler - SCIENCE OF SKINCARE LLC (006251958)