Label: CREAM- zinc oxide cream
- NDC Code(s): 61354-115-01, 61354-115-02
- Packager: Oxygen Development LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure.
Use water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Sun protection measures:
Spending time in the sun increases 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 am-2 pm.
-wear long-sleeved shirts, pants, hats and sunglasses.
-children under 6 months of age: Ask a doctor.
- Other information
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Inactive ingredients
Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice*, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Raspberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizinate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492) *Certified Organic.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21.76 mg in 100 mg Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 0.96 mg in 100 mg WATER (UNII: 059QF0KO0R) 36.09 mg in 100 mg APPLE (UNII: B423VGH5S9) 1.5 mg in 100 mg COCO GLUCOSIDE (UNII: ICS790225B) 1.05 mg in 100 mg POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.96 mg in 100 mg LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 0.96 mg in 100 mg MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 16.85 mg in 100 mg COCONUT ALKANES (UNII: 1E5KJY107T) 4.7 mg in 100 mg RASPBERRY SEED OIL (UNII: 9S8867952A) 0.49 mg in 100 mg PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 100 mg LACTOBACILLUS REUTERI F275 STRAIN (UNII: 3K209OP33H) 0.99 mg in 100 mg GLYCERIN (UNII: PDC6A3C0OX) 4.79 mg in 100 mg CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 4.22 mg in 100 mg ISOSTEARIC ACID (UNII: X33R8U0062) 0.96 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-115-02 1 in 1 CARTON 10/26/2023 1 NDC:61354-115-01 100 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 Drug M020 10/26/2023 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-115)
