Label: THERMASUN ZINXATION MINERAL ZINC FACIAL SUNSCREEN - ACNE PRONE SKIN SPF-50- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 80982-002-37 - Packager: ASTIVITA LIMITED
- Category: HUMAN OTC DRUG LABEL
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 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
• apply liberally and evenly 20 minutes before sun exposure
• reapply: After 40 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 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
• children under 6 months of age: ask a doctor -
INACTIVE INGREDIENTS
Aqua, coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxystearic acid, maltodextrin, matricaria chamomilla (German chamomile extract), phenylpropanol, propanediol, caprylyl glycol, tocopherol (vitamin e), ethylhexylglycerin, cetyl phospate, sodium chloride, disodium EDTA
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERMASUN ZINXATION MINERAL ZINC FACIAL SUNSCREEN - ACNE PRONE SKIN SPF-50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80982-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 g in 120 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) GLYCERIN (UNII: PDC6A3C0OX) COCONUT ALKANES (UNII: 1E5KJY107T) JOJOBA OIL (UNII: 724GKU717M) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) YELLOW WAX (UNII: 2ZA36H0S2V) ISOSTEARIC ACID (UNII: X33R8U0062) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MALTODEXTRIN (UNII: 7CVR7L4A2D) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) PHENYLPROPANOL (UNII: 0F897O3O4M) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETYL PHOSPHATE (UNII: VT07D6X67O) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80982-002-37 120 g in 1 TUBE; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2020 Labeler - ASTIVITA LIMITED (742799513) Establishment Name Address ID/FEI Business Operations ASTIVITA LIMITED 742799513 label(80982-002)
