Label: H SKIN REPAIR - HYDRATE PLUS RESTORE SUNSCREEN SPF30 PLUS BLEMISH FIX TINTED MINERAL MAKEUP- octinoxate and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-7622-1 - Packager: Cosmetic Solutions LLC
- 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 October 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.
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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENTS
Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone, Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/ Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (Cl77491), (Cl77492) (Cl77499).
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
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INGREDIENTS AND APPEARANCE
H SKIN REPAIR - HYDRATE PLUS RESTORE SUNSCREEN SPF30 PLUS BLEMISH FIX TINTED MINERAL MAKEUP
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-7622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Glyceryl Dilaurate (UNII: MFL3ZIE8SK) Cetostearyl Alcohol (UNII: 2DMT128M1S) Yellow Wax (UNII: 2ZA36H0S2V) Dimethicone (UNII: 92RU3N3Y1O) Cyclomethicone (UNII: NMQ347994Z) Diisopropyl Adipate (UNII: P7E6YFV72X) Hexylene Glycol (UNII: KEH0A3F75J) PEG-40 Stearate (UNII: ECU18C66Q7) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Carnauba Wax (UNII: R12CBM0EIZ) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) Sorbitan Tristearate (UNII: 6LUM696811) Stearoxytrimethylsilane (UNII: 9862TW94B2) Steareth-100 (UNII: 4OH5W9UM87) Laureth-7 (UNII: Z95S6G8201) C13-14 Isoparaffin (UNII: E4F12ROE70) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-7622-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2019 Labeler - Cosmetic Solutions LLC (807907928)
