Label: RORY BROAD SPECTRUM SPF 28 SUNSCREEN FACE MOISTURIZER- octinoxate, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72484-202-03 - Packager: Roman Health Ventures Inc.
- Category: HUMAN OTC DRUG LABEL
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 31, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- children under 6 months of age: ask a doctor
- 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
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-10, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Quercus Suber Bark Extract, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak Root Extract, Centella Asiatica Extract, Polygonum Aviculare Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Benzoate, Lepidium Sativum Sprout Extract.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RORY BROAD SPECTRUM SPF 28 SUNSCREEN FACE MOISTURIZER
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72484-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYGONUM AVICULARE WHOLE (UNII: M990N03611) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) COCONUT OIL (UNII: Q9L0O73W7L) EDETATE DISODIUM (UNII: 7FLD91C86K) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) ISOCETYL STEARATE (UNII: 3RJ7186O9W) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ) LEPIDIUM SATIVUM WHOLE (UNII: 0FL88F2R2Q) SORBITOL (UNII: 506T60A25R) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) XANTHAN GUM (UNII: TTV12P4NEE) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) QUERCUS SUBER BARK (UNII: 8R5219271Q) OCTISALATE (UNII: 4X49Y0596W) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLUCONOLACTONE (UNII: WQ29KQ9POT) CALCIUM GLUCONATE (UNII: SQE6VB453K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U) SODIUM BENZOATE (UNII: OJ245FE5EU) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CENTELLA ASIATICA (UNII: 7M867G6T1U) ISOMALT (UNII: S870P55O2W) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) GREEN TEA LEAF (UNII: W2ZU1RY8B0) QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72484-202-03 1 in 1 CARTON 07/28/2020 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/28/2020 Labeler - Roman Health Ventures Inc. (081317350)
