Label: SOFT TOUCH- sunscreen with spf 30 lotion
- NDC Code(s): 81537-105-03, 81537-105-04
- Packager: Danne Montague King
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 11, 2023
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- DESCRIPTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- INSTRUCTIONS FOR USE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
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- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
SOFT TOUCH
sunscreen with spf 30 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81537-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 23.12 g in 100 mL Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.7 g in 100 mL CYCLOMETHICONE 6 (UNII: XHK3U310BA) 6.3 g in 100 mL YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) 0.2 g in 100 mL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 3.5 g in 100 mL SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) 1.2 g in 100 mL GARLIC (UNII: V1V998DC17) 0.3 g in 100 mL COCONUT OIL (UNII: Q9L0O73W7L) 0.3 g in 100 mL POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) 0.68 g in 100 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.8 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.777 g in 100 mL PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.5 g in 100 mL ISOHEXADECANE (UNII: 918X1OUF1E) 1 g in 100 mL WATER (UNII: 059QF0KO0R) 34.858 g in 100 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 9.22 g in 100 mL DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 8 g in 100 mL VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) 2 g in 100 mL ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 0.8 g in 100 mL ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ) 0.025 g in 100 mL POLYGONUM AVICULARE WHOLE (UNII: M990N03611) 0.02 g in 100 mL PHYSALIS ANGULATA (UNII: W4TKW9D5GG) 0.28 g in 100 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.2 g in 100 mL LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.49 g in 100 mL ISOSTEARIC ACID (UNII: X33R8U0062) 0.68 g in 100 mL POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 3.5 g in 100 mL Product Characteristics Color white (Opaque White Lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81537-105-04 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2021 2 NDC:81537-105-03 120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/25/2021 Labeler - Danne Montague King (624242264) Registrant - Danne Montague King (624242264) Establishment Name Address ID/FEI Business Operations Danne Montague King 624242264 label(81537-105) , pack(81537-105) Establishment Name Address ID/FEI Business Operations Creative Essences, Inc. 079120182 manufacture(81537-105)
