Label: NATURAL SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 68062-8307-1
- Packager: Spa de Soleil
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 22, 2022
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- Active Ingredients
- Purpose
- Warnings
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- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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Inactive Ingredients
Inactive Ingredients:
carthamus tinctorius (safflower) seed oil, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, pongamia glabra (karanja) seed oil, vitis vinifera (grape) see oil, olea europaea (olive) oil, argania spinosa (argan) oil, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane
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INGREDIENTS AND APPEARANCE
NATURAL SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-8307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 780 mg in 118 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 900 mg in 118 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) XANTHAN GUM (UNII: TTV12P4NEE) SQUALANE (UNII: GW89575KF9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-8307-1 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/04/2017 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-8307)