Label: EEZYSUN SPF 50- titanium dioxide, zinc oxide cream
- NDC Code(s): 70116-014-01
- Packager: BIO EARTH MANUFACTURING (PTY) LTD
- 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 June 8, 2023
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- Official Label (Printer Friendly)
- Purpose
- Uses
- Warnings
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Direction
- Apply liberally 15 minutes before sun exposure. Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun protection measures. Use a broad spectrum sun-screen with an SPF value of 50 or higher
- limit time in the sun, especially from 10 am - 2 pm
- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte,Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citronella,Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose,Lemongrass, Neem, Polysorbate 20, Potassium Cetyl
Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil - Active ingredients
- Product label
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INGREDIENTS AND APPEARANCE
EEZYSUN SPF 50
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70116-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) BARIUM SULFATE (UNII: 25BB7EKE2E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRONELLA OIL (UNII: QYO8Q067D0) CITRUS X LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SOYBEAN OIL (UNII: 241ATL177A) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CASTOR OIL (UNII: D5340Y2I9G) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) CARNAUBA WAX (UNII: R12CBM0EIZ) ROSA MOSCHATA OIL (UNII: J99W255AWF) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LACTATE (UNII: TU7HW0W0QT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70116-014-01 70 in 1 CARTON 06/30/2023 1 100 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/30/2023 Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436) Establishment Name Address ID/FEI Business Operations BIO EARTH MANUFACTURING (PTY) LTD 639768436 manufacture(70116-014)
