Label: MEDLINE- zinc oxide stick
- NDC Code(s): 53329-220-07
- Packager: Medline Industries, LP
- 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 December 14, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: ask a doctor
- reapply:
- after 80 mins. of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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 sun, especially from 10 a.m. to 2 p.m.
- wear long sleeve shirts, pants, hats and sunglasses
-
Inactive ingredients
aloe barbadensis leaf extract, behenyl behenate, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, polyhydroxystearic acid, ricinus communis (castor) seed oil, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol
- Other information
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- Manufacturing Information
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INGREDIENTS AND APPEARANCE
MEDLINE
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength BEHENYL BEHENATE (UNII: K8NU647RJ0) CANDELILLA WAX (UNII: WL0328HX19) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) SQUALANE (UNII: GW89575KF9) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL (UNII: 724GKU717M) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CASTOR OIL (UNII: D5340Y2I9G) COCOA BUTTER (UNII: 512OYT1CRR) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-220-07 14 g in 1 CONTAINER; Type 0: Not a Combination Product 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/01/2021 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
