Label: ZINC OXIDE stick
ZINC OXIDE lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73418-020-01, 73418-021-01 - Packager: Hello Bello
- 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 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
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USES:
Helps prevent sunburn
- If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun
- WARNING:
- DIRECTIONS:
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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: limited time in the sun, especially from 10 am. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENTS:
Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter*, Prunus Armeniaca (Apricot) Kernel Oil, Argania Spinosa (Argan) Kernel Oil*, Copernicia Cerifera (Carnauba) Wax*, Rosa Canina (Rosehip) Fruit Oil, Tocopherol - *Certified Organic
- Principal Display Panel - 29 g Box Label
- Principal Display Panel - 29 g Stick Label
- Principal Display Panel - 88.7 mL Carton Label
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 22 g in 100 mL Inactive Ingredients Ingredient Name Strength Sunflower Oil (UNII: 3W1JG795YI) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Castor Oil (UNII: D5340Y2I9G) Raspberry Seed Oil (UNII: 9S8867952A) Apricot Kernel Oil (UNII: 54JB35T06A) Argan Oil (UNII: 4V59G5UW9X) Carnauba Wax (UNII: R12CBM0EIZ) Aloe Vera Leaf (UNII: ZY81Z83H0X) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-020-01 1 in 1 BOX 02/01/2019 1 29 mL in 1 APPLICATOR; 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 02/01/2019 ZINC OXIDE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-021 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 mL Inactive Ingredients Ingredient Name Strength Sunflower Oil (UNII: 3W1JG795YI) Coconut Oil (UNII: Q9L0O73W7L) Candelilla Wax (UNII: WL0328HX19) Castor Oil (UNII: D5340Y2I9G) Raspberry Seed Oil (UNII: 9S8867952A) Apricot Kernel Oil (UNII: 54JB35T06A) Argan Oil (UNII: 4V59G5UW9X) Carnauba Wax (UNII: R12CBM0EIZ) Rosa Canina Fruit Oil (UNII: CR7307M3QZ) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-021-01 88.7 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2019 Labeler - Hello Bello (081135707) Establishment Name Address ID/FEI Business Operations Unconditional Love 081135707 MANUFACTURE(73418-020, 73418-021)
