Label: MOISTURIZER- zinc oxide lotion
- NDC Code(s): 61354-042-01, 61354-042-02
- Packager: Oxygen Development LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 4, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using
- Stop use
- Keep out the reach of children
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Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Reapply at least every 2 hours.
use a water resistant sunscreen if swimming or sweating.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thsi risk, regulary use a sunscreen with a Board 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 information
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)
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INGREDIENTS AND APPEARANCE
MOISTURIZER
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.68 mg in 100 mg Inactive Ingredients Ingredient Name Strength COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 5 mg in 100 mg SORBITAN OLIVATE (UNII: MDL271E3GR) 1.52 mg in 100 mg POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3) 1.2 mg in 100 mg HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) 0.6 mg in 100 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.51 mg in 100 mg DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg in 100 mg ISOSTEARIC ACID (UNII: X33R8U0062) 0.78 mg in 100 mg PROPANEDIOL (UNII: 5965N8W85T) 1.6 mg in 100 mg POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 0.78 mg in 100 mg GLYCERIN (UNII: PDC6A3C0OX) 0.65 mg in 100 mg WATER (UNII: 059QF0KO0R) 51.72 mg in 100 mg MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 5.2 mg in 100 mg STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) 2 mg in 100 mg POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1.78 mg in 100 mg GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) 2.19 mg in 100 mg LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 0.88 mg in 100 mg CETEARYL OLIVATE (UNII: 58B69Q84JO) 2.28 mg in 100 mg GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 1.12 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-042-02 1 in 1 CARTON 01/04/2022 1 NDC:61354-042-01 100 mg in 1 TUBE; 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 01/04/2022 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-042)
