Label: AVA ISA EVERY MORNING- zinc oxide lotion
- NDC Code(s): 71644-016-50, 71644-016-80
- Packager: Cyberderm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Adults and children over 6 months of age:
- Apply liberally to face and body 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
Aqua, coco-caprylate/caprate, polyclyceryl-3 polycrinoleate, isostearic acid, caprylic/capric triglyceride, propanediol, C-13-15 alkane, dimethicone/vinyl dimethicone crosspolymer, TMP lauryl dimethicone, caprylhydroxamic acid, 1,2 hexanediol, 7-dehydrocholesterol, sodium chloride, cerium oxide
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVA ISA EVERY MORNING
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71644-016 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 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) LAURYL TRISILOXANE (UNII: 5OHO78HI1D) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ISOSTEARIC ACID (UNII: X33R8U0062) CERIC OXIDE (UNII: 619G5K328Y) C13-15 ALKANE (UNII: 114P5I43UJ) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71644-016-50 1 in 1 CARTON 11/07/2023 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71644-016-80 1 in 1 CARTON 11/07/2023 2 80 mL in 1 BOTTLE; 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 11/07/2023 Labeler - Cyberderm Laboratories Inc. (242524267)
