Label: BALI BLOC SPF 30 COCOA SUNSCREEN- zinc oxide cream
- NDC Code(s): 73369-0008-1
- Packager: Kabana Skin Care 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.
Updated November 4, 2021
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- Active Ingredients
For external use only if used as directed with other sun protection measures
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- after 80 minutes 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 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-sleeve shirts, pants, hats, and sunglasses
- Inactive Ingredients
- Other Information
- Questions or comments?
- Drug Facts
INGREDIENTS AND APPEARANCE
BALI BLOC SPF 30 COCOA SUNSCREEN
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73369-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 g in 100 g Inactive Ingredients Ingredient Name Strength COCOA (UNII: D9108TZ9KG) 15 g in 100 g YELLOW WAX (UNII: 2ZA36H0S2V) 15 g in 100 g COCONUT OIL (UNII: Q9L0O73W7L) 45 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73369-0008-1 110 g in 1 TUBE; Type 0: Not a Combination Product 10/08/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/08/2014 Labeler - Kabana Skin Care LLC (080237112) Registrant - Kabana Skin Care LLC (080237112) Establishment Name Address ID/FEI Business Operations Kabana Skin Care LLC 080237112 manufacture(73369-0008)