Label: PRINCIPAL SECRET RECLAIM SUNSCREEN FOR FACE AND BODY SPF 30- meradimate, octinoxate, oxybenzone, and zinc oxide cream
- NDC Code(s): 70605-014-21
- Packager: Guthy-Renker LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 10, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only.
- Directions
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Inactive ingredients
Water, Ethylhexyl Ethylhexanoate, Pentylene Glycol, Triisononanoin, Sodium Dihydroxycetyl Phosphate, Glyceryl Stearate SE, Cetearyl Alcohol, Beeswax, Glycosaminoglycans, Ahnfeltiopsis Concinna Extract, Acetyl Hexapeptide-8, Phospholipids, Tocopheryl Acetate, Retinyl Palmitate, Cucumis Melo (Melon) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Ascorbyl Palmitate, Pantothenic Acid, Vitis Vinifera (Grape) Leaf Extract, Iris Florentina Root Extract, Hibiscus Abelmoschus Extract, Bisabolol, Hydrogenated Palm Glycerides, Ceteareth-20, Polyglyceryl-3 Caprate, Phytonadione, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Xanthan Gum, Caprylic/Capric Triglyceride, Butylene Glycol, Phenoxyethanol, Methylparaben, Chlorphenesin, Benzoic Acid
- Other Information
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 mL Tube Label
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INGREDIENTS AND APPEARANCE
PRINCIPAL SECRET RECLAIM SUNSCREEN FOR FACE AND BODY SPF 30
meradimate, octinoxate, oxybenzone, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70605-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ) Meradimate 3.5 mg in 100 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 mg in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2 mg in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 3 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ethylhexyl Ethylhexanoate (UNII: 430RJA6715) Pentylene Glycol (UNII: 50C1307PZG) Triisononanoin (UNII: XF4K22WN6T) Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595) Glyceryl Stearate SE (UNII: FCZ5MH785I) Cetostearyl Alcohol (UNII: 2DMT128M1S) Yellow Wax (UNII: 2ZA36H0S2V) Ahnfeltiopsis Concinna (UNII: SMF2K46G8D) Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Lecithin, Soybean (UNII: 1DI56QDM62) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) MUSKMELON (UNII: ZV095H5633) BANANA (UNII: 4AJZ4765R9) Ascorbyl Palmitate (UNII: QN83US2B0N) Pantothenic Acid (UNII: 19F5HK2737) VITIS VINIFERA LEAF (UNII: R1H893D80E) IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD) ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88) LEVOMENOL (UNII: 24WE03BX2T) Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) Phytonadione (UNII: A034SE7857) Polyacrylamide (10000 MW) (UNII: E2KR9C9V2I) C13-14 Isoparaffin (UNII: E4F12ROE70) Laureth-7 (UNII: Z95S6G8201) Xanthan Gum (UNII: TTV12P4NEE) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Butylene Glycol (UNII: 3XUS85K0RA) Phenoxyethanol (UNII: HIE492ZZ3T) Methylparaben (UNII: A2I8C7HI9T) Chlorphenesin (UNII: I670DAL4SZ) Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70605-014-21 75 mL in 1 TUBE; Type 0: Not a Combination Product 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 04/30/2016 Labeler - Guthy-Renker LLC (948861877)